Single operator exchange fluid jet thrombectomy device

ABSTRACT

A single operator exchange fluid jet thrombectomy device having an outer catheter assembly and separable and exchangeable components in the form of an inner catheter assembly allowing functioning as a rheolytic thrombectomy catheter or as a crossflow thrombectomy catheter. Embodiments include an outer catheter assembly common to any mode of usage having a guide catheter having a lumen through which a guidewire and the greater portion of a hypo-tube carrying a flow director are passed and advanced. For use as a rheolytic thrombectomy catheter, thrombus is dislodged, entrained, and broken into pieces by jets and evacuated through the lumen of the guide catheter. For use as a crossflow thrombectomy catheter, a flow director having outflow and inflow orifices is provided.

CROSS REFERENCES TO CO-PENDING APPLICATIONS

This patent application is a continuation-in-part of Ser. No.09/356,783, entitled “Rheolytic Thrombectomy Catheter and Method ofUsing Same”, filed on Jul. 16, 1999, now abandoned, which is adivisional of Ser. No. 09/019,728, entitled “Rheolytic ThrombectomyCatheter and Method of Using Same”, filed on Feb. 6, 1998, U.S. Pat. No.5,989,210.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an interchangeable and separablecatheter system for alternatively incorporating the principles of arheolytic thrombectomy catheter or the principles of a crossflowthrombectomy catheter, or of the simultaneous use of the principles ofboth the rheolytic thrombectomy catheter and the crossflow thrombectomycatheter.

The present invention relates to apparatus for use in treatment of thehuman body. More particularly, the present invention relates to anelongated device which may be a single catheter assembly or a multiplecomponent catheter assembly and which is suitable for use throughpercutaneous or other access, for endoscopic procedures, or forintraoperative use in either open or limited access surgical procedures.Still more particularly, the present invention relates to an elongateddevice in the form of a rheolytic thrombectomy catheter or, alternately,in the form of a fluid jet thrombectomy catheter, the latter hereinaftertermed crossflow thrombectomy catheter, and having a commonly used outercatheter assembly, each device being incorporated for fragmentation andremoval of thrombus or other unwanted material from blood vessels orbody cavities, and each device using high velocity saline (or othersuitable fluid) jets to macerate the thrombus or other unwantedmaterial. The elongated device bears certain similarities to a knownwaterjet thrombectomy catheter and can be used as such, but differstherefrom in several material respects, a major distinction being in theprovision of interchangeable alternate means which produce inwardlydirected jets with or without crossflow jets. The crossflow jets createa recirculation flow pattern optimized for clearing a large crosssection of mural thrombus or other similar material, the name crossflowthrombectomy catheter deriving from this major distinction. Further, thepresent invention also relates to a system constituted either by thecombination of the elongated device with both pressurized fluid sourcemeans and exhaust regulation means or by the combination of theelongated device with only pressurized fluid source means.

2. Description of the Prior Art

Procedures and devices have been developed for ease in removing tissueand various deposits. Several such devices employ a jet of saline as theworking tool to help break up the tissue deposit and further provide asuction means to remove the deposit. U.S. Pat. No. 5,135,482 to Neracherdescribes a hydrodynamic device for removal of organic deposit from ahuman vessel. A supply of saline is delivered by a high pressure duct tothe distal end of a catheter. The saline exits the duct as a jet that isdirected generally forward and directly toward the tissue to be brokenup. The duct is contained within and can move axially with respect to ahose that is positioned around the duct. A vacuum suction is applied tothe hose to remove the debris that is created from the broken-up tissue.This device is not intended to pass through tortuous pathways found inthe fragile vessels of the body, and any attempt to employ the devicefor such purpose would be far too traumatic to the patient.

Another drainage catheter, described by Griep in U.S. Pat. No.5,320,599, has a discharge channel and a pressure channel. The channelsare formed into a single catheter tube such that the two tubes are fixedwith respect to each other.

Waterjet thrombectomy catheters have been described in which adistal-to-proximal-directed waterjet(s) flow(s) past a window, orificeor gap at the distal end of the catheter, re-entering the catheter andpushing flow through an evacuation lumen. When placed in a vesselcontaining thrombus and activated, the high velocity jet(s) will entrainsurrounding fluid and thrombus into the window, orifice or gap region,where the high shear forces of the jet(s) will macerate the thrombus.The macerated particles will be removed from the body by the pressuregenerated on the distal end of the evacuation lumen by the impingementof the high velocity waterjet(s).

A limitation of these waterjet thrombectomy catheters has been theinability to remove organized, wall-adherent thrombus from largevessels. In accordance with the present invention, the single operatorexchange fluid jet thrombectomy device described overcomes thislimitation by optimizing the recirculation pattern at the tip of thedevice to increase the drag force exerted on the mural thrombus to breakit free from the vessel wall and allow it to be removed by the device.

Prior art devices often required the use of more than one operator whereone operator must stabilize the guidewire while the second operatorintroduces the catheter over the guidewire into the anatomy.

The present invention overcomes the disadvantages of the current devicesby providing an interchangeable catheter system utilizing either therheolytic thrombectomy catheter or the crossflow thrombectomy catheter,each of which can be operated by one practitioner, and which offersmultiple advantages over previous rheolytic thrombectomy catheterdesigns. More specifically, the present invention is incorporated forremoval of unwanted deposits in the body, such as, but not limited to,deposits in bile ducts, the brain or other hematomas, and brainventricles, for example.

SUMMARY OF THE INVENTION

The present invention, a single operator exchange fluid jet thrombectomydevice, is a surgical device for removal of material such as thrombusfrom a vessel or other body cavity. As shown in one or more embodiments,the single operator exchange fluid jet thrombectomy device can functionas a rheolytic thrombectomy catheter for removing tissue from a vesselor other body cavity and includes an outer catheter assembly common toany mode of operation, the commonly used outer catheter assembly ofwhich is comprised of a manifold and a first tube or guide catheterhaving a lumen with an open distal end, the lumen being of a diametersufficient to allow passage of an inner catheter assembly. One suchinner catheter assembly as incorporated in use with the single operatorexchange fluid jet thrombectomy device is comprised of a high pressuresecond tube having a high pressure lumen and a geometrically configureddistally located jet emanator having one or more rearwardly directedorifices for directing one or more jets of saline toward the distal endof a flow director, a proximally located transitional stop fixed to thesecond tube adjacent to the second tube proximal end, and an exhausttube. The inner catheter assembly is movable axially within the outercatheter assembly such that the proximally located transitional stopengages the proximally located stationary stop to hold the jet emanatorin a desired relationship with respect to the distal end of the outercatheter assembly.

The single operator exchange fluid jet thrombectomy device, the presentinvention, provides a catheter combination for use as a rheolyticthrombectomy catheter including the first tube or guide catheter, beinga part of a common use outer assembly, the first tube or guide catheterhaving a proximal end, a manifold attached thereto, an open distal end,and a lumen extending between the proximal end and the open distal end;the second tube, being a part of an inner catheter assembly, the secondtube being separable from the first tube or guide catheter and beinginsertable within the lumen of the first tube or guide catheter, thesecond tube having a proximal end, a distal end, and a lumen extendingbetween the proximal end and the distal end; a flow director having aninner body and an exhaust tube which may or may not be expandable, eachbeing located near but not at the second tube distal end, a pressureoperated sealable or closely fit annulus between the outer surface ofthe exhaust tube and the interior annular surface of the first tube orguide catheter, a jet emanator integrally formed at the distal end ofthe second tube or attached thereto by a bonding operation into which atleast one jet orifice is machined or otherwise formed on the proximalside thereof to create a jet emanator for directing fluid proximally forthrombus ablation and subsequently through a lumen in the flow directorand the lumen of the first tube or guide catheter, being also a part ofthe inner catheter assembly, the jet emanator and flow director,including the inner body thereof, being capable of passage through thelumen of the first tube or guide catheter and over a guidewire, andbeing characterized by the ability to provide a localized region of lowpressure associated with a liquid flow directed generally proximally andinto the inner body, into an exhaust tube, and into the lumen of thefirst tube or guide catheter through the distal end of the first tube orguide catheter. A variable displacement distance means for indexing anappropriate positional and variable relationship of the jet emanator tothe distal end of the first tube or guide catheter is provided. A stopmeans is provided for limiting movement of the second tube andpreferably includes a proximally located hemostasis nut/stop at theproximal end of a manifold of the outer catheter assembly and aproximally located filter housing/high pressure connection/stop assemblyprojecting outwardly from the proximal end of the second tube. When thesecond tube is advanced within the first tube or guide catheter,fluoro-imaging can be incorporated to provide adequate spacing andrelationship between the jet emanator and the distal end of the firsttube or guide catheter. This relationship is also referred to asvariable displacement distance. Lateral positioning of the second tubewithin the first tube or guide catheter is readily accomplished duringthe first stage (insertion) in an unpressurized operational mode wherethe sealable or closely fit annulus is suitably sized to allow easyunrestricted passage of the second tube within and through the firsttube or guide catheter. A representative exhaust tube is shown in manyembodiments with additional reference to the following exhaust tubetypes including, but not limited to, an exhaust tube which can becompliant expandable where the diameter of the exhaust tube depends onapplied pressure and subsequent restriction by the guide catheter, anon-compliant expandable exhaust tube where the diameter of the exhausttube is dependent on the designed diameter or the exhaust tube can benot expandable, but closely fit to the first tube or guide catheter.During the operational pressurized mode, jetted saline causes anexpandable exhaust tube to expand, thus partially or fully closing,restricting, modifying or eliminating the open annulus to pressure sealthe first tube or guide catheter to the second tube, but still allowingmovement relative to each other. In the alternative, a closely fitannulus incorporating a non-expandable exhaust tube offers partial buteffective restrictive closing to substantially pressure seal or closethe first tube or guide catheter to the second tube.

The above embodiment of the present invention provides a method ofremoving thrombus from an obstructed body vessel. The method includesthe steps of:

a. providing a guidewire and an outer catheter assembly including amanifold, a first tube or guide catheter having an interior annularsurface, a distal end, and an externally located stationary hemostasisnut/stop positioned at the manifold proximal end;

b. advancing the first tube or guide catheter proximal to a vascularsite containing thrombus;

c. advancing the guidewire through the first tube or guide catheter andpast the vascular site containing thrombus;

d. providing an inner catheter assembly including a second tube carryinga jet emanator at its distal end, a flow director including anexpandable or non-expandable exhaust tube proximal of the jet emanator,and a transitional filter housing/high pressure connection/stop assemblyat its proximal end;

e. advancing the inner catheter assembly to a desired position withinthe first tube or guide catheter, so that a gap or space proximal to thejet emanator extends past the distal end of the first tube or guidecatheter, while the proximal end of the flow director remains proximalto the distal end of the first tube or guide catheter;

f. providing a high pressure saline supply to the second tube so as tocause at least one jet of saline to emanate from the jet emanator and toentrain thrombus into the gap or space where the thrombus is maceratedand then pushed through the flow director and into the first tube orguide catheter for removal from the body; and,

g. providing impingement of at least one jet on the interior annularsurface of an exhaust tube to create sufficient stagnation pressure toexpand the exhaust tube against the interior annular surface of thefirst tube or guide catheter or utilize a closely fit annulus and forceevacuation of debris through the flow director and the first tube orguide catheter out of the body with no need for additional suction.

In the method, the inner catheter assembly can be moved axially relativeto both the first tube or guide catheter and guidewire to facilitatedistal and proximal movement of the inner catheter assembly to removethrombus distributed axially throughout the vasculature.

An alternate embodiment includes a crossflow/flow director inserted intothe common outer catheter assembly to function substantially asdescribed above, but to include the features and functions of acrossflow thrombectomy catheter.

One significant aspect and feature of the present invention is a singleoperator exchange fluid jet thrombectomy device operable by onepractitioner.

Another significant aspect and feature of the present invention is asingle operator exchange fluid jet thrombectomy device having an outercatheter assembly which can accommodate various inner catheterassemblies configured to function either as a rheolytic thrombectomycatheter or as a crossflow thrombectomy catheter.

Another significant aspect and feature of the present invention is atransitional filter housing/high pressure connection/stop assembly onthe proximal end of the second tube which impinges a hemostasis nut/stopon the manifold to position the jet emanator at a defined distancebeyond the distal end of the guide catheter.

Other significant aspects and features of the present invention are atransitional filter housing/high pressure connection/stop assemblyproximally located at the end of the inner catheter assembly and astationary hemostasis nut/stop proximally located on the outer catheterassembly which engage to prevent the inner catheter assembly from beingexcessively advanced, so that the exhaust tube proximal end does notbecome disengaged from the distal end of the first tube or guidecatheter.

A further significant aspect and feature as found in additionalembodiment groups is an annulus which is open for lateral movement ofthe inner catheter assembly within the outer catheter assembly duringthe initial unpressurized mode (insertion) and which can be modulated toa partially or fully closed position and sealed by jetted saline duringthe ablation process to provide maximum proximally directed saline flowwith minimum or no leakage between the outer and inner catheterassemblies when thrombotic tissue is broken up and carried proximally.

Another significant aspect and feature of the present invention is aflow director which can use either a compliant expandable, anon-compliant expandable, a non-expandable, non-compliant close fit, ora combination compliant/non-compliant exhaust tube.

Yet another significant aspect and feature of the present invention isthe ability to incorporate various emanator shapes, styles and designs.

Another significant aspect and feature of the present invention is theability to reduce cost aspect since effluent outflow or exhaust can becollected using a standard Y-connector.

Having thus described embodiments and significant aspects and featuresof the present invention, it is the principal object of the presentinvention to provide a single operator exchange fluid jet thrombectomydevice and method of using same to remove thrombus from a body vessel orother body cavity.

One object of the present invention is to provide a single operatorexchange fluid jet thrombectomy device of such size, flexibility andconstruction as to enable it to pass readily through the tortuouspathways found in the fragile vessels of the brain or other body areas.

Another object of the present invention is to provide a single operatorexchange fluid jet thrombectomy device with means for producing one ormore jets of saline and projecting them in a proximal direction tocreate a vacuum near the site of thrombus while pressurizing theevacuation passage.

Yet another object of the present invention is to provide a singleoperator exchange fluid jet thrombectomy device with means for producingone or more jets of saline and with indexing means to position the jetproducing means at a prescribed location at the distal end of thedevice.

Still another object of the present invention is to provide a singleoperator exchange fluid jet thrombectomy device of the type having aninner catheter assembly that is insertable into an outer catheterassembly with stop means for limiting the extent to which the innercatheter assembly can be inserted into the outer catheter assembly.

A further object of the present invention is to provide a singleoperator exchange fluid jet thrombectomy device of the type having aninner catheter assembly and an outer catheter assembly with means whichcenters the inner catheter assembly within the outer catheter assemblyand which orients the components of the inner catheter assembly in aprescribed manner with respect to the components of the outer catheterassembly.

A still further object of the present invention is that smaller cathetersizes can be used with single operator exchange design withoutdecreasing the exhaust flow rate, since the majority of length forevacuation is the inner diameter of the guide catheter, thus requiringless pressure drop than if evacuation all had to occur through a thirdtube that passed through the guide catheter lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects of the present invention and many of the attendantadvantages of the present invention will be readily appreciated as thesame becomes better understood by reference to the following detaileddescription when considered in connection with the accompanyingdrawings, in which like reference numerals designate like partsthroughout the figures thereof and wherein:

FIG. 1 is a simplified block diagram view of the present invention, asingle operator exchange fluid jet thrombectomy device useful for theremoval of thrombus;

FIG. 2 illustrates a side view of a single operator exchange fluid jetthrombectomy device;

FIG. 3 illustrates a semi-exploded side view of the single operatorexchange fluid jet thrombectomy device;

FIG. 4 illustrates an isometric view of the distal end of the first tubeor guide catheter with a portion of the inner catheter assemblyprotruding therefrom;

FIG. 5 illustrates an exploded view of the components of FIG. 4;

FIG. 6 illustrates an isometric view of one jet emanator means, atoroidal loop;

FIG. 7 illustrates a cross section view of the distal end of the firsttube or guide catheter and the flow director in the unpressurized mode,along the line 7—7 of FIG. 2;

FIG. 8 illustrates a cross section view of the elements of FIG. 7 in thepressurized mode;

FIG. 9 illustrates a cross section view of the elements of FIG. 7 in thepartially pressurized mode;

FIG. 10 illustrates a cross section view of the junction of the innerbody and the expandable exhaust tube along line 10—10 of FIG. 7;

FIG. 11 illustrates a cross section view at the distal end of the firsttube or guide catheter along line 11—11 of FIG. 7 in the unpressurizedmode;

FIG. 12 illustrates a cross section view at the distal end of the firsttube or guide catheter along line 12—12 of FIG. 8 in the pressurizedmode;

FIG. 13 illustrates a cross section view at the distal end of the firsttube or guide catheter along line 13—13 of FIG. 9 in the partiallypressurized mode;

FIG. 14, a first alternative embodiment, illustrates a cross sectionview of the elements of FIG. 7 featuring an optional non-compliantexpandable exhaust tube;

FIG. 15 illustrates the non-compliant expandable exhaust tube of FIG. 14in the inflated mode to close a previously open annulus;

FIG. 16, a second alternative embodiment, illustrates a cross sectionview of the elements of FIG. 7 featuring an optional non-expandable,non-compliant fit tube;

FIG. 17, a third alternative embodiment, illustrates a cross sectionview of the elements of FIG. 7 featuring a compliant/non-compliantexhaust tube where one segment is more flexible than an adjacentsegment;

FIG. 18 illustrates a cross section view and in partial cutaway of thedistal end of the single operator exchange fluid jet thrombectomy devicein operation in a blood vessel;

FIG. 19, a fourth alternative embodiment, illustrates a side view of asingle operator exchange fluid jet thrombectomy device incorporating aninner catheter assembly having a crossflow capability;

FIG. 20 illustrates a semi-exploded side view of the single operatorexchange fluid jet thrombectomy device of FIG. 19;

FIG. 21 illustrates an isometric view of the distal end of the firsttube or guide catheter with a portion of the inner catheter assembly ofFIG. 20 protruding therefrom;

FIG. 22 illustrates an exploded view of the components of FIG. 21;

FIG. 23, a fifth alternative embodiment, illustrates a view of theelements of FIG. 6 including one or more outflow orifices;

FIG. 24 illustrates a cross section view of the distal end of the firsttube or guide catheter and the crossflow/flow director in theunpressurized mode, along line 24—24 of FIG. 19;

FIG. 25 illustrates a cross section view of the elements of FIG. 24 inthe pressurized mode;

FIG. 26, a sixth alternative embodiment, illustrates a cross sectionview of the elements of FIG. 24 featuring a non-compliant expandableexhaust tube;

FIG. 27 illustrates the non-compliant expandable exhaust tube of FIG. 26in the inflated mode to close the previously open annulus;

FIG. 28, a seventh alternative embodiment, illustrates a cross sectionview of the elements of FIG. 24 featuring an optional non-expandable,non-compliant close fit exhaust tube;

FIG. 29, an eighth alternative embodiment, illustrates a cross sectionview of the elements of FIG. 24 featuring an optionalcompliant/non-compliant exhaust tube;

FIG. 30 illustrates a view in cross section and in partial cutaway ofthe mode of operation of the single operator exchange fluid jetthrombectomy device utilizing the inner catheter assembly of FIG. 24;

FIG. 31, a ninth alternative embodiment, illustrates an exploded view ofa jet emanator in the form of a jet cap;

FIG. 32 illustrates an assembled view of the elements of FIG. 31;

FIG. 33 illustrates a cross section view of the jet cap along line 33—33of FIG. 32;

FIG. 34, a tenth alternative embodiment, illustrates an isometric viewof a jet cap having formed passages;

FIG. 35 illustrates a side view of the formed passage jet cap in use asan emanator;

FIG. 36 illustrates a proximal view of the formed passage jet cap;

FIG. 37, an eleventh alternative embodiment, illustrates a cross sectionview of an inner body along line 37—37 of FIG. 38;

FIG. 38 illustrates an end view of the inner body along line 38—38 ofFIG. 37;

FIG. 39, a twelfth alternative embodiment, illustrates a cross sectionview of an inner body along line 39—39 of FIG. 40;

FIG. 40 illustrates an end view of the inner body along line 40—40 ofFIG. 39;

FIG. 41, a thirteenth alternative embodiment, illustrates a crosssection view of a first tube or guide catheter having a distally locatedinflatable balloon;

FIG. 42 illustrates the first tube or guide catheter of FIG. 41 in usein a blood vessel;

FIG. 43, a fourteenth alternative embodiment, illustrates a crosssection view of a first tube or guide catheter having a distally locatedinflatable balloon and another inflatable balloon located proximal tothe distally located inflatable balloon;

FIG. 44 illustrates the first tube or guide catheter of FIG. 43 in usein a blood vessel;

FIG. 45, a fifteenth alternative embodiment, illustrates a side view ofa single operator exchange fluid jet thrombectomy device;

FIG. 46 illustrates a semi-exploded side view of the single operatorexchange fluid jet thrombectomy device of FIG. 45;

FIG. 47 illustrates a cross section view along line 47—47 of FIG. 45 ofthe single operator exchange fluid jet thrombectomy device;

FIG. 48 illustrates the elements of FIG. 45 having a second tube of apredetermined length to limit the distance a jet emanator can travelbeyond the distal end of the first tube or guide catheter;

FIG. 49 illustrates the use of a centering ring with the elements ofFIGS. 45, 46, 47 and 48;

FIG. 50 illustrates a semi-exploded side view of the elements of FIG.49; and,

FIG. 51 illustrates a cross section view of the single operator exchangefluid jet thrombectomy device along line 51—51 of FIG. 49.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates in block diagram form a single operator exchangefluid jet thrombectomy device 10 according to one embodiment of thepresent invention showing the interrelation of the various functionalmeans thereof for use in removing thrombus or other unwanted materialfrom a body vessel or cavity.

The major components of the system include an elongated device in theform of a single operator exchange fluid jet thrombectomy device, apressurized fluid source means, and, optionally, an exhaust regulationmeans connected to a collection system (not shown).

The elongated device includes first and second tubular means each havinga proximal end and a distal end. The second tubular means is in the formof a high pressure tubular means having pressurized fluid connectionmeans providing a fluid connection permanently or detachably coupled toits proximal end and jet emanator means at its distal end, thepressurized fluid connection means being connectible to the pressurizedfluid source means. The first tubular means is in the form of either anexhaust tubular means, as shown, or other tubular means (not shown inFIG. 1 but described in detail in relation to FIGS. 2 and 3) whichserves as an alternative to an exhaust tubular means in those instanceswhen exhausting is not necessary or desired. When in the form of anexhaust tubular means, the first tubular means is usually associatedwith exhaust regulation means, although an exhaust regulation means isnot essential. Whether in the form of an exhaust tubular means or othertubular means, the first tubular means includes outflow means and inflowmeans which in concert with high velocity jet(s) produced by the jetemanator means create rheolytic fluid flow or create optional crossflowjet(s) that establish a flow recirculation pattern, depending on thestyle of second tubular means.

The optional outflow means (crossflow) consists of one or more outfloworifices through which saline, blood or other fluid or a mixture thereofwith macerated thrombus or other unwanted material debris flows from aregion of higher pressure within the exhaust tubular means or othertubular means to outside the exhaust tubular means or other tubularmeans. The one or more outflow orifices are typically somewhatdownstream from the high velocity region of the high velocity jet(s)where the velocities are lower and the mass flow rate is greater due toentrained fluid; and flow of fluid with or without macerated debristypically flows through the one or more outflow orifices with acomponent in the radial direction, creating crossflow jet(s). Theoutflow orifices may be round, elliptical, conical, slits, gaps betweencomponents, or other shapes or designs.

The optional inflow means (crossflow) consists of one or more infloworifices through which the high velocity jet(s) draw in by fluidentrainment blood or other fluid from a body vessel or cavity, includingthrombus or other unwanted material which may be present in the blood orother fluid. The one or more inflow orifices are typically near the highvelocity region of the high velocity jet(s) where entrainment forces aregreat. The inflow orifices may be round, elliptical, conical, slits,gaps between components, or other shapes or designs.

The high pressure tubular means comprises an elongated structure havingat least one passage or lumen along the length thereof suitable forpassage of high pressure fluid. The elongated structure can be tubingwith a circular or non-circular cross section and can be made of highstrength polymeric material such as polyimide, metallic material such asstainless steel or titanium, or composite material such asfiber-reinforced material or a layered structure composed of layers ofdifferent materials.

The exhaust tubular means comprises an elongated structure having atleast one passage or lumen along the length thereof suitable for passageof fluid and thrombus or other unwanted material debris. The elongatedstructure can be tubing with a circular or non-circular cross sectionand can be made of polymeric material such a polyethylene, polyester,polyurethane, or polyether block amide; high strength polymeric materialsuch as polyimide; metallic material such as stainless steel ortitanium; or composite material such as fiber-reinforced polymericmaterial or a layered structure composed of layers of differentmaterials. Further, the elongated structure may have an attachedstructure near its distal end such as a chamber or manifold toaccommodate the inflow means and optional outflow means.

The other tubular means comprises an elongated structure having at leastone passage or lumen along the length thereof suitable for passage offluid. The elongated structure can be tubing with a circular ornon-circular cross section or may resemble a shorter chamber such as amanifold, molded or constructed of multiple components. Suitablematerials for the other tubular means are polymeric material such aspolyethylene, polyester, or polyurethane; high strength polymericmaterial such as polyimide; metallic material such as stainless steel ortitanium; or composite material such as fiber-reinforced polymericmaterial or a layered structure composed of layers of differentmaterials.

If desired, isolation means (not shown) can be provided as part of theelongated device to isolate the region of the body vessel or cavitybeing treated, although this is not always required. Isolation means caninclude balloons, filters, baskets, membranes, blood pressuremodification, fluid flow control, or other occlusion devices such as areknown in the art. Isolation means can limit passage of debris in theblood vessel, limit the flow of blood in the area of the elongateddevice, or confine the recirculation area. Also if desired, additionaltubular means can be provided for communication between the proximal endand the distal end of the elongated device, such as for passage of fluidor other material or for passage of devices such as guidewires,catheters, or imaging tools, or for actuation of isolation means, forinflation of a balloon, or for passage of medication or body fluids. Theadditional tubular means (not shown) comprises an elongated structurehaving at least one passage or lumen along the length thereof; forexample, the elongated device can include a multiple-lumen tube, inwhich one lumen functions as the high pressure tubular means, a secondlumen functions as the exhaust tubular means, and one or more additionallumens function as the additional tubular means which communicatesbetween the proximal and distal ends of the elongated device.

The pressurized fluid source means includes fluid such as saline and oneor more pumps or pressure intensifiers or pressurized fluid containersfor delivering the fluid under pressure to the high pressure tubularmeans through the pressurized fluid connection means coupled to theproximal end thereof. The fluid can be provided at a single pressure orat multiple pressures, at variable or adjustable pressure, and at asteady flow or unsteady flow such as pulsatile flow.

The exhaust regulation means, when present, comprises structuralcomponents which increase, decrease, limit, or adjust the rate of flowof fluid and thrombus or other unwanted material debris along theexhaust tubular means and can be one or more pumps such as roller pumpsor peristaltic pumps, clamps, restrictors, or other devices to influencethe fluid flow rate. The exhaust regulation means can regulate exhaustat a predetermined or user-adjustable flow rate which can be correlatedwith or independent of the rate of flow of the pressurized fluid flowingalong the high pressure tubular means. Further, the exhaust regulationmeans can have pressure measurement or flow rate measurementcapabilities. The exhaust regulation means is connected to a suitablecollection system (not shown).

The system is placed in operation by first inserting the first tubularmeans into a body vessel or cavity and advancing it to a site ofthrombus or other unwanted material in the body vessel or cavityfollowed by insertion of a guidewire which is inserted to or past thesite of the thrombus or other unwanted material. Subsequently, thesecond tubular means is advanced along the guidewire and is accommodatedby the first tubular means. Then the proximal end of the second tubularmeans is connected to the pressurized fluid source means which providespressurized saline (or other biologically compatible fluid) to theproximal end of the high pressure tubular means via the pressurizedfluid connection means. At the distal end of the high pressure tubularmeans, pressurized saline (or other fluid) passes into the jet emanatormeans which produces high velocity saline (or other fluid) jet(s). Thehigh velocity saline (or other fluid) jet(s) entrain blood or otherfluid from the body vessel or cavity and draw it into the distal portionof the elongated device through the inflow means, carrying thrombus orother unwanted material from the body vessel or cavity along with theblood or other fluid. The high velocity saline (or other fluid) jet(s)together with the entrained blood or other fluid create a region ofelevated pressure in the elongated device; this region of elevatedpressure communicates with or is a part of the distal portion of theexhaust tubular means. Optionally, the elevated pressure in the elevatedpressure region drives fluid flow through the outflow means, creatingcrossflow jet(s) which have a radial component and may havecircumferential and/or axial component(s) as well. The fluid in theelevated pressure region includes saline (or other fluid) from the highvelocity jet(s) as well as the entrained blood or other fluid from thebody vessel or cavity. The crossflow jet(s) impart normal and dragforces on thrombus or other unwanted material in the body vessel orcavity and greatly improve the effectiveness of the device in removingand breaking apart thrombus or other unwanted material which may beadhered to the body vessel or cavity, and form a recirculation patternwhich further aids in drawing thrombus or other unwanted materialtowards the inflow means. The combination of outflow means, crossflowjet(s), recirculation pattern, inflow means, and high velocity jet(s)synergistically acts to provide for enhanced breakup and removal ofthrombus or other unwanted material. The elevated pressure in theelevated pressure region can also aid in the transport of fluid andthrombus or other unwanted material debris through the exhaust tubularmeans. If desired, the rate of flow of fluid and thrombus or otherunwanted material can be regulated by providing exhaust regulationmeans, although this is not always required.

FIG. 2 illustrates a side view of a single operator exchange fluid jetthrombectomy device 10 useful for the removal of thrombus, and FIG. 3illustrates a semi-exploded side view of the single operator exchangefluid jet thrombectomy device 10. The single operator exchange fluid jetthrombectomy device 10 includes two major assemblies: namely, an outercatheter assembly 12, which is a core assembly, and an inner catheterassembly 14 configured to function as a rheolytic thrombectomy catheter,which can be exchanged with other styles or designs of inner catheterassemblies, as desired, such as shown in FIGS. 19 and 20, to fitsubstantially within the outer catheter assembly 12. The outer catheterassembly 12 is preferably a standard guide catheter, but may also be acatheter specifically designed for this application. The outer catheterassembly 12 design should have proper torque, stiffness, and shape toplace the device in the thrombus containing blood vessel. The innercatheter assembly 14, when in use, aligns substantially concentricallyto and mostly within the outer catheter assembly 12 and extends beyondboth ends of the outer catheter assembly 12. A guidewire 16 including aflexible tip 18 at one end and a proximal end 17 opposing the flexibletip 18 is shown in substantially concentric alignment to both the outercatheter assembly 12 and the inner catheter assembly 14. Externallyvisible components, or portions of components, of the outer catheterassembly 12 and of the inner catheter assembly 14 of the single operatorexchange fluid jet thrombectomy device 10, as illustrated in FIGS. 2 and3, also include a manifold 20, also known as a Y-adapter, a hemostasisnut/stop 22 secured in the proximal end 24 of the manifold 20, a Luerconnection 26 located at the proximal end 28 of an angled manifoldbranch 30 extending from the manifold 20, and a first tube or guidecatheter 32, having a Luer connection 35 at a proximal end 33, securedto distal end 34 of the manifold 20 by Luer fitting 36. Opposingmanipulating tabs 38 and 40 are also provided near the proximal end 33of the first tube or guide catheter 32. The externally visiblecomponents of the inner assembly 14, illustrated in FIG. 2, also includea high pressure second tube 42, a transitional filter housing/highpressure connection/stop assembly 44 concentrically aligned to andsecured over and about the proximal end 46 of the second tube 42, a flowdirector 48 a comprised substantially of an exhaust tube in general andgenerally referred to as exhaust tube 72, which is further andspecifically referred to and specified as either a compliant expandableexhaust tube 72 a, a non-compliant expandable exhaust tube 72 b, or anon-expandable, non-compliant close fit exhaust tube 72 c aligned overand about the distal end 50 (FIG. 4) of the second tube 42, an optionaljet cap 54 having a central passage 55 (FIG. 4) aligned to and securedover and about a jet emanator 52 which could be and which is shown as atoroidal loop 52 a having a passage 53 (FIG. 5) at the distal end 50 ofthe second tube 42, a radio-opaque marker 56 aligned over and about adistal end 60 of the first tube or guide catheter 32 and a radio-opaquemarker 58 located at the distal end 57 of the exhaust tube 72, whichcould be and which is shown as a compliant expandable exhaust tube 72 a,to mark the substantially co-located distal end 50 of the second tube 42and distal end 62 of the inner catheter assembly 14 including the jetemanator 52 and optional jet cap 54. An optional radio-opaque marker 59can also be located and attached to or be integral to the proximal end63 of the exhaust tube 72 and included, along with radio-opaque marker58, as an optional integral part of the flow director 48 a. An innerbody 66, part of the flow director 48 a, frictionally engages the distalend 57 of the exhaust tube 72 of the flow director 48 a, as laterdescribed in detail. The high pressure second tube 42 can be drawn andtapered in incremental steps to provide degrees of flexibility along itslength. For purposes of example and illustration, the second tube 42 caninclude an initial and proximal outer diameter of 0.018 inch or smaller,and can include a plurality of incrementally stepped down portions eachof lesser outer diameter, where the last portion is stepped down to anouter diameter of 0.008 inch at the distal end 50 (FIG. 4). The secondtube 42 becomes increasingly more flexible from the proximal end 46towards the distal end 50 due to the incremental diameter decrease alongits length. Increasing flexibility along the length of the second tube42 allows for easier flexed penetration into tortuous vascular paths.Although the second tube 42 is stepped down in increments, the secondtube 42 can also be fashioned of a constantly decreasing outer diameterto provide increasing flexibility along its length and shall not beconstrued to be limiting to the scope of the invention.

FIG. 4 illustrates an isometric view of the distal end 60 of the firsttube or guide catheter 32 with a portion of the inner catheter assembly14 protruding therefrom, and FIG. 5 illustrates an exploded view of thecomponents of FIG. 4. Illustrated in particular is the relationship ofthe components aligned in the distal end 60 of the first tube or guidecatheter 32 during use of the invention, where an exhaust tube 72 in theform of a compliant expandable exhaust tube 72 a is utilized. Guidewire16 is not shown for purposes of brevity and clarity. The second tube 42extends proximally through the flow director 48 a, and collectively thesecond tube 42 and the flow director 48 a extend proximally through thefirst tube or guide catheter 32. As illustrated in the unpressurizedmode in FIG. 4 and as also illustrated in the unpressurized mode in FIG.7, it is noted that an annulus 68 is formed between the interior annularsurface 64 of the first tube or guide catheter 32 and an outer annularsurface 70 a of an exhaust tube 72. During normal pressurized operation,an exhaust tube 72, in this case a compliant expandable exhaust tube 72a, expands to cause the outer annular surface 70 a of an exhaust tube 72to expand and impinge the interior annular surface 64 of the first tubeor guide catheter 32, thereby closing the annulus 68, as later describedin detail. The inner body 66 includes a reduced radius neck 74interrupted by an annular barb 76 both of which are accommodated by theinterior annular surface 78 at the distal end 57 of exhaust tube 72. Thereduced radius neck 74 also includes a slotted cutout 80 (FIG. 10) formounting, such as by welds 81 and 83 or other suitable means, of thedistal end 50 of the second tube 42. Also included, and as shown inFIGS. 5 and 7, in the interior of the inner body 66 is a passage 82having a ramped annular surface 84. A space 88 is located between theinner body 66 and the jet emanator 52 where the thrombus is maceratedand then pushed through the flow director 48 a and into the first tubeor guide catheter 32 for removal from the body.

During use of the invention the outer catheter assembly 12 is advancedalong a vein or other blood vessel or passage to a vascular sitecontaining thrombus followed by the passage of the guidewire 16 throughand beyond the distal end 60 of the first tube or guide catheter 32 andthence followed by advancement of the inner catheter assembly 14 alongthe guidewire 16 and along the interior of the outer catheter assembly12. As the second tube 42 is positioned, during pressurized orunpressurized operation, the flow director 48 a, the jet emanator 52,the optional jet cap 54, along with the second tube 42, move andposition as a unit to a desired position along a variable displacementdistance 86 which is the distance from the distal end 60 of the firsttube or guide catheter 32 to and including the optional jet cap 54. Thevariable displacement distance 86 can range from a minimum distancewhere the jet emanator 52, or the optional jet cap 54, at the distal end50 of the second tube 42 is positioned just inside the distal end 60 ofthe first tube or guide catheter 32, where no thrombus ablation occurs,to a maximum distance where the jet emanator 52, or the optional jet cap54, has advanced to a position well beyond the distal end 60 of thefirst tube or guide catheter 32, thus positioning the proximal end 63 ofan exhaust tube 72 along a region proximal to the distal end 60 of thefirst tube or guide catheter 32, whereby a major portion of the exhausttube 72, the entire inner body 66, the jet emanator 52, and the optionaljet cap 54 are distally located with reference to the distal end 60 ofthe first tube or guide catheter 32. At or near this extended position,further distal movement is prevented by impingement of the transitionalfilter housing/high pressure connection/stop assembly 44 with thehemostasis nut/stop 22, which are shown in FIG. 2.

FIG. 6 illustrates an isometric view of one jet emanator 52 means, beinga toroidal loop 52 a, which may be utilized at the distal end 50 of thesecond tube 42 to direct high velocity jet streams proximally along ornear the longitudinal axis of the second tube 42 and an exhaust tube 72.Any jet emanator means such as the ones shown herein for the presentinvention or the ones shown in related patent application Ser. No.09/417,395 by the inventors which comprise a distal tubular structure ofa high pressure tubular means, such as the second tube 42, through whichpressurized fluid flows creating high velocity fluid jets which emanatefrom one or more orifices in the distal tubular structure, can be used.The distal tubular structure can be of straight, curved, L-shaped,J-shaped, U-shaped, helical, toroidal or semi-toroidal shape, or can bea chamber such as a manifold, and may be formed of a single component,such as a metal hypo-tube, or of multiple components, such as multiplehypo-tubes, welded manifold components, or molded manifold components.The distal tubular structure forming the jet emanator means may beformed as a unitary part of the high pressure tubular means such as byforming a metal hypo-tube into a toroidal shape, or one of the othershapes mentioned above, with a single orifice or multiple orificesproduced by drilling or cutting. The orifices can be round, slits, orother shapes so that fluid flowing therethrough forms one or morediscrete high velocity fluid jets or merges into combination jets.Alternatively, the distal tubular structure forming the jet emanatormeans may be a separate structure having any one of the aforementionedshapes and orifice constructions which is attached to the distal end ofthe high pressure tubular means. In either event, the distal tubularstructure forming the jet emanator means is in fluid communication withthe high pressure tubular means. In any circumstance, highly pressurizedfluid(s) first passes through a lumen of the high pressure tubular meansenroute to the variously shaped and configured distally located jetemanator means.

As previously mentioned, FIG. 6 illustrates an isometric view of the jetemanator 52 in the form of a toroidal loop 52 a which is located at thedistal end 50 of the second tube 42, the jet emanator 52 being sometimesreferred to as a jet body. Illustrated in particular are a plurality ofproximally directed jet orifices 90 a-90 n located on the proximalsurface of the toroidal loop 52 a which direct high velocity jet streamsproximally, as shown by dashed lines, along or near the longitudinalaxis of the second tube 42 and the exhaust tube 72 which, of course, canbe one of several styles described. The toroidal loop 52 a includes acircular passage 53 along the inner circumference to provide for, toaccommodate alignment of, and to permit passage along a guidewire, suchas the guidewire 16 shown partially in FIG. 18. Multiple jet orifices 90a-90 n located at points along the toroidal loop 52 a can advantageouslydirect high velocity jet streams on multiple sides of the guidewire 16when it is positioned in the passage 53 to avoid having guidewire 16block or hamper the macerating effect of the jet streams on thromboticmatter.

FIGS. 7, 8 and 9 substantially illustrate the mutual accommodation andthe alignment of the distal portions of the outer catheter assembly 12and inner catheter assembly 14, where exhaust tube 72 is in the form ofa compliant expandable exhaust tube 72 a.

FIG. 7 illustrates a cross section view of the distal end 60 of thefirst tube or guide catheter 32 and the flow director 48 a in theunpressurized mode, including the second tube 42 and the flow director48 a in extended concentric alignment with the first tube or guidecatheter 32 and associated components, along line 7—7 of FIG. 2.Illustrated in particular is the relationship of the interior annularsurface 64 of the first tube or guide catheter 32 and the outer annularsurface 70 a of an exhaust tube 72, in the form of a compliantexpandable exhaust tube 72 a, which form the annulus 68 which iselongated. Typically, the compliant expandable exhaust tube 72 a can befashioned of, but not limited to, materials such as urethane orsilicone, for example. A horizontally aligned slotted cutout 80 (FIG.10) in the upper region of the inner body 66 accommodates the distal end50 of the second tube 42 which suitably secures and seals therein. Alsoillustrated is the optional jet cap 54 which secures at the distal end50 of the second tube 42 over and about the jet emanator 52. Theoptional jet cap 54 includes passage 55 which intersects a proximallyfacing annular capturing cavity 92 which accommodatingly accepts andfits and secures to the toroidal loop 52 a, a jet emanator 52. Jetorifices 90 a-90 n located on toroidal loop 52 a at the distal end 50 ofthe second tube 42 are directed rearwardly and slightly towards thelongitudinal axis of the exhaust tube 72 and of the inner body 66. Thepredetermined and suitable space 88 is located between the proximalregion of a jet emanator 52, and, in general, the distal end 57 of theexhaust tube 72, and, more specifically, the distal end of the rampedannular surface 84 of the inner body 66. The maximum distal position ofthe space 88 with relation to the distal end 50 of the second tube 42can be determined, if so constructed using a suitable length second tube42, by the relationship of the distal end of the transitional filterhousing/high pressure connection/stop assembly 44 (FIG. 2) and thehemostasis nut/stop 22 which contact each other to limit the distalmovement of the second tube 42. The location of space 88 can also bedetermined by observation of the relationship of one or more of thefollowing components, including the radio-opaque marker 56 at the distalend 60 of the first tube or guide catheter 32, the radio-opaque marker59, the radio-opaque marker 58, the inner body 66, the jet cap 54, or ofother components by known observation methods. The second tube 42 can befashioned of material such as, but not limited to, stainless steel ornickel titanium alloys.

FIG. 8 illustrates a cross section view of the elements of FIG. 7,including the second tube 42 and the flow director 48 a in extendedconcentric alignment with the first tube or guide catheter 32 andassociated components in the pressurized mode. Subsequent to properpositioning of the appropriate component of the invention in a vessel orother body member in the unpressurized mode, saline 94, under highpressure, is injected through the inner catheter assembly 14 through ahigh pressure lumen 93 of the second tube 42 and delivered to the distalend 50 to emanate as saline jet flow 96 from the jet orifices 90 a-90 nof the toroidal loop 52 a. The pressurized saline jet flow 96 isdirected partially into the ramped annular surface 84 and the passage 82of the inner body 66 and partially into the lumen 98 of the exhaust tube72 to pressurize the exhaust tube 72 causing the exhaust tube 72 in theform of a compliant expandable exhaust tube 72 a to expand and force theouter annular surface 70 of the exhaust tube 72 to seal against theinterior annular surface 64 of the first tube or guide catheter 32. Thesaline jet flow 96 also flows to entrain thrombotic tissue adjacent toor lying within the space 88 to break up and erode the thrombotictissue. Positive pressurized flow of the pressurized saline and theentrained particles of thrombotic tissue is prevented from back flowingout of the previously open annulus 68 which has been subsequently closedby the seal between the inner catheter assembly 14 within the outercatheter assembly 12 and is allowed to travel under full pressurizedforce along the lumen 98 of the exhaust tube 72 and along a lumen 100central to the first tube or guide catheter 32 and thence through acatheter lumen interior to the manifold 20 and outwardly through theangled manifold branch 30. The ability to insert and maneuver the innercatheter assembly 14 within the outer catheter assembly 12 freely andunhampered and then to subsequently effect a seal between the innercatheter assembly 14 and the outer catheter assembly 12 whilemaintaining maneuverability contributes to the novelty and usefulness ofthe invention.

FIG. 9 illustrates a cross section view of the elements of FIG. 7,including the second tube 42 and the flow director 48 a in extendedconcentric alignment with the first tube or guide catheter 32 andassociated components in a partially pressurized mode or when theexpandable exhaust tube is deliberately undersized to prevent a completeseal from being made. This figure illustrates the partially pressurizedmode where it is desirable to have the annulus 68 reduced in size fromthat shown in FIG. 7. Such reduction allows more freedom of longitudinaland rotational movement and maneuverability between the inner catheterassembly 14 and the outer catheter assembly 12 while still maintaining asuitable seal. Freedom of rotational movement is desirable to permitgreater flexibility with respect to full and effective radialpositioning of the space 88. Sufficient saline pressure may still bemaintained and any pressure loss through the reduced size annulus 68 isnegligible.

FIG. 10 illustrates a cross section view of the junction of the innerbody 66 and the exhaust tube 72 along line 10—10 of FIG. 7. Illustratedin particular is the mounting and the securing of the second tube 42 toopposing sides of the slotted cutout 80 in the reduced radius neck 74and/or ramped annular surface 84 of the inner body 66 by welds 81 and83. Positioning and securing of the second tube 42 in the upper regionof the inner body 66 ensures alignment of the optional jet cap 54 and ajet emanator 52 with the inner body 66.

FIG. 11 illustrates a cross section view at the distal end 60 of thefirst tube or guide catheter 32 along line 11—11 of FIG. 7 in theunpressurized mode. Illustrated in particular is the annulus 68 betweenthe interior annular surface 64 and the outer annular surface 70.Annulus 68 allows for ready and adequate passage of the flow director 48a through the first tube or guide catheter 32 subsequent to positioningof the outer catheter assembly 12 (FIG. 3).

FIG. 12 illustrates a cross section view at the distal end 60 of thefirst tube or guide catheter 32 along line 12—12 of FIG. 8 in thepressurized mode. Illustrated in particular is the closing orelimination of the annulus 68 (FIG. 7) between the interior annularsurface 64 and the outer annular surface 70 a. Closing of the annulus 68allows for sealing of the flow director 48 a against the interiorannular surface 64 to maintain full pressurization.

FIG. 13 illustrates a cross section view at the distal end 60 of thefirst tube or guide catheter 32 along line 13—13 of FIG. 9 in thepartially pressurized mode or non-sealing design. Illustrated inparticular is the reduction in size of the annulus 68 (FIG. 7) betweenthe interior annular surface 64 and the outer annular surface 70 a.

FIG. 14, a first alternative embodiment, illustrates a cross sectionview of the elements such as described in FIG. 7, including the secondtube 42 and an optional flow director 48 b in loose and non-regularalignment with the first tube or guide catheter 32 and associatedcomponents. This embodiment operates much the same as previousembodiments, but differs from the previous embodiments in that anoptional flow director 48 b is provided which includes the components ofthe flow director 48 a with the exception of an exhaust tube 72 in theform of an optional non-compliant expandable exhaust tube 72 b. Thenon-compliant expandable exhaust tube 72 b can be fashioned of material,such as, but not limited to, flexible polyethylene or polyethyleneterephthalate, for example, and can be expanded from an irregular orbaggy appearing tubular structure to a regular appearing shapedstructure, such as shown in FIG. 15.

FIG. 15 illustrates a cross section view of the elements of FIG. 14 inthe pressurized mode where the exhaust tube 72 in the form of anon-compliant expandable exhaust tube 72 b is pressurized by highpressure saline 94 emanating as saline jet flow 96 from a jet emanator52, depicted more specifically as a toroidal loop 52 a, thereby causingthe non-compliant expandable exhaust tube 72 b to expandingly assume aregular shape and structure which forces the outer surface 70 b (nowannular) to closingly seal against the interior annular surface 64 ofthe first tube or guide catheter 32 to close the previously open annulus68.

FIG. 16, a second alternative embodiment, illustrates a cross sectionview of the elements such as depicted in FIG. 7, including the secondtube 42 and an optional flow director 48 c in extended concentricalignment with the first tube or guide catheter 32 and associatedcomponents. This embodiment operates much the same as previousembodiments, but differs from the previous embodiments in that anoptional flow director 48 c is provided which includes the components ofthe flow director 48 a with the exception of an exhaust tube 72 in theform of an optional non-expandable, non-compliant close fit exhaust tube72 c. The non-expandable, non-compliant close fit exhaust tube 72 c canbe fashioned of material, such as, but not limited to, PEBAX or nyloncopolymer, for example, and is of a regular shaped structure, such as,but not limited to, a tube. This figure illustrates the pressurized modewhere it is desirable to have the annulus 68 not entirely closed. Suchan arrangement allows more freedom of longitudinal and rotationalmovement and maneuverability between the inner catheter assembly 14 andthe outer catheter assembly 12 while still maintaining a suitable seal.Freedom of rotational and longitudinal movement is desirable to permitgreater flexibility with respect to full and effective positioning ofthe space 88. Sufficient saline pressure may still be maintained and anypressure loss through the reduced size annulus 68 is negligible.

FIG. 17, a third alternative embodiment, illustrates a cross sectionview of the elements of FIG. 7, including the second tube 42 and anoptional flow director 48 d in extended concentric alignment with thefirst tube or guide catheter 32 and associated components. Thisembodiment operates much the same as previous embodiments, but differsfrom the previous embodiments in that an optional flow director 48 d isprovided which includes the components of the flow director 48 a of FIG.7 with the exception of an exhaust tube 72 in the form of an optionalcompliant/non-compliant exhaust tube 72 d having continuous segments ofdifferent durometer characteristics whereby one segment is of differentflexibility than an adjacent segment. Segment 102 a is of a durometerreading consistent with the compliant expandable exhaust tube 72 a,previously described, which allows expansion of the segment 102 a, suchas previously described. Segment 102 b, however, is of a durometerreading which is consistent with the non-compliant expandable exhausttube 72 b such that expansion of the segment 102 b is prevented orlimited by its own structure to maintain a constant or near constantdiameter. Alternatively, the segments 102 a and 102 b could be ofseparate construction and joined such as by gluing, ultrasonic welding,fusing, or any suitable method to provide the compliant/non-compliantexhaust tube 72 d.

Mode of Operation

FIG. 18 illustrates a cross section view in partial cutaway of thedistal end of the single operator exchange fluid jet thrombectomy device10 in operation in a blood vessel 104. FIG. 18, with reference toelements previously described in relation to FIGS. 1-13, bestillustrates the mode of operation of the single operator exchange fluidjet thrombectomy device 10, with particular attention to the distal end60 of the first tube or guide catheter 32, the flow director 48 a, thesecond tube 42, the jet emanator 52 and the optional jet cap 54 andguidewire 16 positioned in a blood vessel 104, artery or the like at thesite of a thrombotic deposit or lesion 106.

The first tube or guide catheter 32, which is flexible and which servesas a flexible evacuation tube, is first advanced to reach a locationproximal of the thrombotic deposit or lesion 106. With the distal end 60of the first tube or guide catheter 32 positioned near the thromboticdeposit or lesion 106, the flexible tip 18 of the guidewire 16 is thenintroduced into the first tube or guide catheter 32 via the manifold 20and thence the guidewire 16 is advanced through and past the distal end60 of the first tube or guide catheter 32 and then along a blood vessel104 or vein in the patient's body. The guidewire 16 is advanced throughthe vasculature to and beyond the site of the thrombotic deposit orlesion 106. For a distal coronary vessel or a vessel of the brain,typically the guidewire has a diameter which can range from 0.010-0.018inch. This invention can also be applied to larger vessels which requirelarger diameter guidewires up to 0.038 inch. Once the guidewire 16 hasbeen advanced along the blood vessel 104 and has reached or has beenadvanced through the thrombotic deposit or lesion 106, the innercatheter assembly 14 can be brought into engagement with the catheterassembly 12. Such engagement is initiated by accommodation of theguidewire 16 by the passage 53 of the jet emanator 52 and the passage 55of the optional jet cap 54, if incorporated. The inner catheter assembly14 is then advanced distally whereby the proximal end 17 of theguidewire 16 enters the space 88 and the components of the flow director48 a to subsequently extend proximally from the flow director 48 a.Further advancement of the inner catheter assembly 14 along theguidewire 16 brings the jet emanator 52 and optional jet cap 54 and theflow director 48 a of the inner catheter assembly 14 and the second tube42 into aligned accommodation initially by the manifold 20 and then bythe first tube or guide catheter 32. The jet emanator 52, the optionaljet cap 54, the flow director 48 a, which can have a lubricous coatingto aid in deployment through the lumen 100 of the first tube or guidecatheter 32, and the second tube 42 are then advanced within the lumen100 of the first tube or guide catheter 32 to a position along thevariable displacement distance 86 where the distal end 57 of the exhausttube 72, in this case in the form of a compliant expandable exhaust tube72 a, and including the inner body 66 are positioned as desired beyondthe distal end 60 of the first tube or guide catheter 32, whereby theexhaust tube 72 is aligned to the distal end 60 of the first tube orguide catheter 32. The passage 82 of the inner body 66, the lumen 98 ofthe exhaust tube 72, and the lumen 100 of the first tube or guidecatheter 32 serve as an evacuation tube. The single operator exchangefluid jet thrombectomy device 10 can then be activated by providing highpressure liquid, preferably saline, to the proximal end 33 of the firsttube or guide catheter 32 via the manifold 20.

High pressure saline 94, or other liquid, from the manifold 20 isprovided and flows through the high pressure lumen 93 of the second tube42 to enter orifices 90 a-90 n of the jet emanator 52. The high pressuresaline exits the jet emanator 52 as high velocity saline jet flow 96directed toward the open ramped annular surface 84 and enters into thepassage 82 of the inner body 66 at the distal end 57 of the exhaust tube72. The high pressure saline jet flow operates to close the annulus 68to ensure positive flow without leak-back through an annulus such asannulus 68, as previously described, and to dislodge tissue from thethrombotic deposit or lesion 106 and entrain the tissue into the salinejet flow 96 where it is broken up into smaller fragments and carriedproximally.

Impingement of the saline jet flow 96 into the flow director 48 a andthe first tube or guide catheter 32 creates a stagnation pressure withinthe lumen 98 of the exhaust tube 72 and the lumen 100 of the first tubeor guide catheter 32 (evacuation lumen) that drives the debris particlesof thrombotic deposit or lesion 106 toward the proximal end 33 of thefirst tube or guide catheter 32.

Subsequent to initial activation, the inner catheter assembly 14 can beadvanced over the guidewire 16 through tortuous turns to reach thethrombotic deposits or lesions 106 beyond the region of initial ablativeaction for further ablative action.

A positive displacement piston pump (not illustrated) can be used toprovide liquid, preferably saline, under pressure to the proximal end ofthe second tube 42. A pressure ranging from 50-50,000 psi will providethe energy to create a useful high velocity saline jet flow 96 as thesaline exits the jet orifices 90 a-90 n located at the proximal surfaceof the jet emanator 52. The flow rate of saline can be controlled byadjusting the pumping rate of the positive displacement piston pump. Theproximal end 33 of the first tube or guide catheter 32 interfaces with ametering device through the Luer connection 26 at the manifold branch30, for example, a roller pump, prior to discharge of the evacuatedthrombotic debris into a collection bag for disposal. The rate ofevacuation can be controlled by adjusting the rate of the roller pump.The rate of saline inflow can be balanced with the rate of removal ofthrombotic debris by simultaneous adjustment of the piston pump and theroller pump. The rate of saline inflow can be less than, equal to, orgreater than the rate of removal of thrombotic debris. The rate ofthrombus removal can be set to slightly exceed the rate of saline inflowto reduce the likelihood for distal embolization of thrombotic tissue.

Because numerous modifications may be made to this invention withoutdeparting from the spirit thereof, the scope of the invention is not tobe limited to the embodiments illustrated and described. Rather, thescope of the invention is to be determined by the appended claims andtheir equivalents.

FIG. 19, a fourth alternative embodiment, illustrates a side view of asingle operator exchange fluid jet thrombectomy device 110 useful forthe removal of thrombus, and FIG. 20 illustrates a semi-exploded sideview of the single operator exchange fluid jet thrombectomy device 110.The single operator exchange fluid jet thrombectomy device 110 includestwo major assemblies: namely, an outer catheter assembly 12, aspreviously described in detail and which is a core assembly, and aninner catheter assembly 114 configured to function as a crossflowthrombectomy catheter, which has been substituted or exchanged for thepreviously described inner catheter assembly 14 and which is shown as anexample of inner catheter assemblies which can be exchanged with otherstyles or designs of inner catheter assemblies as desired to fitsubstantially within and to be incorporated with the outer catheterassembly 12. The inner catheter assembly 114, when in use, alignssubstantially concentrically to and mostly within the outer catheterassembly 12 and extends beyond both ends of the outer catheter assembly12. Guidewire 16 including a flexible tip 18 at one end and a proximalend 17 opposing the flexible tip 18 is shown in substantially concentricalignment to both the outer catheter assembly 12 and the inner catheterassembly 114. Externally visible components, or portions of components,of the outer catheter assembly 12 correspond to the previousdescriptions. Much of the structure of the previously described innercatheter assembly 14 is incorporated and utilized in the inner catheterassembly 114. Externally visible components or portions of components ofthe inner catheter assembly 114 of the single operator exchange fluidjet thrombectomy device 110 include the high pressure second tube 42,the transitional filter housing/high pressure connection/stop assembly44 concentrically aligned to and secured over and about the proximal end46 of the second tube 42, a crossflow/flow director 116 a having a lumen154 (FIG. 24) and comprised substantially of an exhaust tube 122 in theform of a compliant expandable exhaust tube 122 a aligned over and aboutthe distal end 50 (FIG. 4) of the high pressure second tube 42, aflexible tapered tip 117 having a passage 119 (FIG. 21) and beingcontiguous with and extending distally from the exhaust tube 122 of thecrossflow/flow director 116 a, the end of the flexible tapered tip 117at the passage 119 being the distal end 124 of the inner catheterassembly 114, a jet emanator 52 having a passage 53 (FIG. 22) at thedistal end 50 of the second tube 42, and a radio-opaque marker 118located along and at the distal end 120 of the crossflow/flow director116 a and aligned adjacent to and in close proximity to the jet emanator52 to mark the substantially co-located distal end 50 of the second tube42 and distal end 120 of the crossflow/flow director 116 a. An optionalradio-opaque marker 126 can also be located and attached to or beintegral to the proximal end 128 of the crossflow/flow director 116 aand included, along with radio-opaque marker 118, as an optionalintegral part of the crossflow/flow director 116 a. An inner body 130 ofeither metal or plastic (FIG. 22), part of the crossflow/flow director116 a, frictionally engages the distal end 120 of the crossflow/flowdirector 116 a interior of the exhaust tube 122 of the crossflow/flowdirector 116 a, as shown in FIG. 24. Also featured on the exhaust tube122 of the crossflow/flow director 116 a are one or more outfloworifices 134 and one or more inflow orifices 136 for creating acrossflow so that the inner catheter assembly will function as acrossflow thrombectomy catheter. An optional radio-opaque marker 127 canbe included on the exhaust tube 122 of the crossflow/flow director 116 abetween one or more outflow orifices 134 and one or more inflow orifices136.

FIG. 21 illustrates an isometric view of the distal end 60 of the firsttube or guide catheter 32 with a portion of the inner catheter assembly114 protruding therefrom, and FIG. 22 illustrates an exploded view ofthe components of FIG. 21. Illustrated in particular is the relationshipof the components aligned in the distal end 60 of the first tube orguide catheter 32 during use of the invention. Guidewire 16 is not shownfor purposes of brevity and clarity. The second tube 42 extendsproximally through the crossflow/flow director 116 a, and collectivelythe second tube 42 and the crossflow/flow director 116 a extendproximally through the first tube or guide catheter 32. As illustratedin the unpressurized mode and as also illustrated in FIG. 24, it isnoted that an annulus 138 is formed between the interior annular surface64 of the first tube or guide catheter 32 and an outer annular surface140 of the exhaust tube 122, which is in the form of a compliantexpandable exhaust tube 122 a. The inner body 130 includes a reducedradius neck 142 extending proximally from a larger radius shoulder 144and also includes a passage 146 for accommodation of the guidewire 16.The jet emanator 52, in the form of a toroidal loop 52 a, aligns to andsecures, such as by welding, gluing or other suitable means, to theproximal region of the inner body 130, as shown in FIG. 24. Swaging ofthe radio-opaque marker 118 over the exhaust tube 122 and inner body 130secures the assembly in order to keep the distance from the jet emanator52 and inflow orifices 136 constant for optimal thrombectomy function.During normal pressurized operation, the exhaust tube 122 expands tocause the outer annular surface 140 of the exhaust tube 122 to expandand impinge the interior annular surface 64 of the first tube or guidecatheter 32, thereby closing and eliminating the annulus 138, much thesame as previously described for use of the inner catheter assembly 14with the outer catheter assembly 12 and as later shown in FIG. 25. Also,pressurized saline flow passes from the outflow orifice(s) 134 todislodge thrombotic materials which are returned to the interior oflumen 154 of the crossflow/flow director 116 a through the infloworifice(s) 136 where the thrombus is macerated and then pushed throughthe crossflow/flow director 116 a and into the first tube or guidecatheter 32 for removal from the body.

During use of the invention the outer catheter assembly 12 is advancedalong a vein or other blood vessel or passage proximal to a vascularsite containing thrombus followed by the passage of the guidewire 16through and beyond the distal end 60 of the first tube or guide catheter32 and thence followed by advancement of the inner catheter assembly 114along the guidewire 16 and along the interior of the outer catheterassembly 12. As the second tube 42 is positioned, during pressurized orunpressurized operation, the crossflow/flow director 116 a, the jetemanator 52, along with the second tube 42, move and position as a unitto a desired position along a variable displacement distance 148 whichis the distance from the distal end 60 of the first tube or guidecatheter 32 to and including the distal end 120 of the crossflow/flowdirector 116 a. The variable displacement distance 148 can range from aminimum distance where the jet emanator 52 at the distal end 50 of thesecond tube 42 (distal end 120 of the crossflow/flow director 116 a) ispositioned just inside the distal end 60 of the first tube or guidecatheter 32, where no thrombus ablation occurs, to a maximum distancewhere the jet emanator 52 has advanced to a position well beyond thedistal end 60 of the first tube or guide catheter 32, thus positioningthe proximal end 128 of the crossflow/flow director 116 a along a regionproximal to the distal end 60 of the first tube or guide catheter 32,whereby a major portion of the exhaust tube 122, the entire inner body130, and the jet emanator 52 are distally located with reference to thedistal end 60 of the first tube or guide catheter 32. Incrementaladvancement distally of the crossflow/flow director 116 a distallyreveals the inflow orifice(s) 136 and the outflow orifice(s) 134sequentially. In some cases, it would be advantageous to operate withthe outflow orifices 134 blocked when treating a soft unstable thrombusto remove easily embolized material, and then operate with the outfloworifices 134 exposed to remove the more strongly adherent thrombus orother tissue. At or near this extended position, further distal movementis prevented by impingement of the transitional filter housing/highpressure connection/stop assembly 44 with the hemostasis nut/stop 22,which are shown in FIG. 19.

FIG. 23, a fifth alternative embodiment, illustrates a view of theelements of FIG. 6 including one or more optional outflow orifice(s) 170for incorporation of saline crossflow with the inner catheter assembly14 of the single operator exchange fluid jet thrombectomy device shownin FIG. 2. High pressure saline jet flow 96 emanating from the jetemanator 52 initially enters passage 82, flows through passage 82 intothe exhaust tube 72 to outflow orifice(s) 170, exits radially to form acrossflow jet 172 to impinge and entrain thrombotic deposits or lesions,and thence is directed distally and drawn again through passage 82 ofthe inner body 66, which functions as an inflow orifice, where thethrombotic deposits or lesions are macerated by the high pressure salinejet flow 96 to be further entrained by the high pressure saline jet flow96 for travel along the lumen 98 of the exhaust tube 72. Thus,maceration including the attributes of saline crossflow jets, such ascrossflow jet 172, and the attributes of maceration occurring at thespace 88 are combined.

FIGS. 24 and 25 substantially illustrate the mutual accommodation andthe alignment of the distal portions of the outer catheter assembly 12and inner catheter assembly 114.

FIG. 24 illustrates a cross section view of the distal end 60 of thefirst tube or guide catheter 32 and the crossflow/flow director 116 a inthe unpressurized mode, including the second tube 42 and thecrossflow/flow director 116 a in extended concentric alignment with thefirst tube or guide catheter 32 and associated components, along line24—24 of FIG. 19. Illustrated in particular is the relationship of theinterior annular surface 64 of the first tube or guide catheter 32 andthe outer annular surface 140 of the exhaust tube 122, in the form of acompliant expandable exhaust tube 122 a, which form the annulus 138which is elongated. Jet orifices 90 a-90 n (FIG. 6) located at jetemanator 52 at the distal end 50 of the second tube 42 are directedrearwardly and slightly towards the longitudinal axis of the exhausttube 122.

The maximum distal position of the distal end 50 of the second tube 42with respect to the distal end 60 of the first tube or guide catheter 32can be determined by using a suitable length second tube 42. The distalend of the transitional filter housing/high pressure connection/stopassembly 44 (FIG. 19) and the hemostasis nut/stop 22 (FIG. 19) cancontact each other to limit the distal movement of the second tube 42and the attached crossflow/flow director 116 a. The location of thecrossflow/flow director 116 a and its position with respect to thedistal end 60 of the first tube or guide catheter 32 can also bedetermined by observation of the relationship of one or more of thefollowing components, including the radio-opaque marker 56 at the distalend 60 of the first tube or guide catheter 32, the radio-opaque markers126 and 127, the radio-opaque marker 118, the inner body 130, theflexible tapered tip 117, or of other components by known observationmethods.

FIG. 25 illustrates a cross section view of the elements of FIG. 24,including the second tube 42 and the crossflow/flow director 116 a inextended concentric alignment with the first tube or guide catheter 32and associated components, in the pressurized mode. Subsequent to properpositioning of the appropriate component of the invention in a vessel orother body member in the unpressurized mode, saline 150, under highpressure, is injected through the inner catheter assembly 114 throughthe high pressure lumen 93 of the second tube 42 and delivered to thedistal end 50 to emanate as saline jet flow 152 from the jet orifices 90a-90 n of the jet emanator 52. The pressurized saline jet flow 152 isdirected proximally into the lumen 154 of the crossflow/flow director116 a where it (1) operates to pressurize the exhaust tube 122 causingthe exhaust tube 122, in the form of a compliant expandable exhaust tube122 a, to expand and force the outer annular surface 140 of the exhausttube 122 to closingly seal against the interior annular surface 64 ofthe first tube or guide catheter 32, (2) exits one or more outfloworifices 134 to break up and erode the thrombotic tissue, and (3)entrains loosened thrombotic tissue adjacent to and about the exposedportion of the crossflow/flow director 116 a and to return the loosenedthrombotic material through one or more inflow orifices 136. Positivepressurized flow of the pressurized saline prevents saline from backflowing out of the previously open annulus 138 which has beenpressurized to the closed position by creation of a seal between theinner catheter assembly 114 within the outer catheter assembly 12 andallows the saline to travel while carrying the entrained particles ofthrombotic tissue under full pressurized force along the lumen 154 ofthe crossflow/flow director 116 a and along a lumen 100 central to thefirst tube or guide catheter 32 and thence through a catheter lumeninterior to the manifold 20 and outwardly through the angled manifoldbranch 30 where its flow may or may not be regulated. The ability toinsert and maneuver the inner catheter assembly 114 within the outercatheter assembly 12 freely and unhampered and then to subsequentlyeffect a seal between the inner catheter assembly 114 and the outercatheter assembly 12 while maintaining maneuverability contributes tothe novelty and usefulness of the invention.

FIG. 26, a sixth alternative embodiment, illustrates a cross sectionview of the elements of FIG. 24, including the second tube 42 and anoptional crossflow/flow director 116 b in loose and non-regularalignment with the first tube or guide catheter 32 and associatedcomponents. This embodiment operates much the same as a previousembodiment(s), but differs from the previous embodiments in that anoptional crossflow/flow director 116 b is provided which includes thecomponents of the crossflow/flow director 116 a with the exception of anexhaust tube 122 in the form of a non-compliant expandable exhaust tube122 b. The non-compliant expandable exhaust tube 122 b can be fashionedof material, such as, but not limited to, flexible polyethylene orpolyethylene terephthalate, for example, and can be expanded from anirregular or baggy appearing tubular structure to a regular appearingshaped structure, such as shown in FIG. 27.

FIG. 27 illustrates a cross section view of the elements of FIG. 26 inthe pressurized mode where the exhaust tube 122 in the form of anon-compliant expandable exhaust tube 122 b is pressurized by highpressure saline 150 emanating as saline jet flow 152 from a jet emanator52, depicted specifically as a toroidal loop 52 a, thereby causing thenon-compliant expandable exhaust tube 122 b to expandingly assume aregular shape and structure which forces the outer surface 140 (nowannular) to closingly seal against the interior annular surface 64 ofthe first tube or guide catheter 32 to close the previously open annulus138.

FIG. 28, a seventh alternative embodiment, illustrates a cross sectionview of the elements of FIG. 24, including the second tube 42 and anoptional flow director 116 c in extended concentric alignment with thefirst tube or guide catheter 32 and associated components. Thisembodiment operates much the same as previous embodiments, but differsfrom the previous embodiments in that an optional flow director 116 c isprovided which includes the components of the flow director 116 a withthe exception of an exhaust tube 122 in the form of an optionalnon-expandable, non-compliant close fit exhaust tube 122 c. Thenon-expandable, non-compliant close fit exhaust tube 122 c can befashioned of material, such as, but not limited to, PEBAX or nyloncopolymer, for example, and is of a regular shaped structure, such as,but not limited to, a tube. This figure illustrates the pressurized modewhere it is desirable to have the annulus 138 not entirely closed. Suchan arrangement allows more freedom of longitudinal and rotationalmovement and maneuverability between the inner catheter assembly 114 andthe outer catheter assembly 12 while still maintaining a suitable seal.Freedom of rotational movement is desirable to permit greaterflexibility with respect to full and effective radial positioning of theinner catheter assembly 114. Sufficient saline pressure may still bemaintained and any pressure loss through the reduced size annulus 138 isnegligible.

FIG. 29, an eighth alternative embodiment, illustrates a cross sectionview of the elements of FIG. 24, including the second tube 42 and anoptional flow director 116 d in extended concentric alignment with thefirst tube or guide catheter 32 and associated components. Thisembodiment operates much the same as previous embodiments, but differsfrom the previous embodiments in that an optional flow director 116 d isprovided which includes the components of the flow director 116 a ofFIG. 24 with the exception of an exhaust tube 122 in the form of anoptional compliant/non-compliant exhaust tube 122 d having continuoussegments of different durometer characteristics whereby one segment ismore flexible than an adjacent segment. Segment 214 a is of a durometerreading consistent with the compliant expandable exhaust tube 122 apreviously described which allows expansion of the segment 214 a, suchas previously described. Segment 214 b, however, is of a durometerreading which is consistent with the non-compliant expandable exhausttube 122 b such that expansion of the segment 214 b is prevented orlimited by its own structure to maintain a constant or near constantdiameter. Alternatively, the segments 214 a and 214 b could be ofseparate construction and joined such as by gluing, ultrasonic welding,fusing, or any suitable method to provide the compliant/non-compliantexhaust tube 122 d.

Mode of Operation

FIG. 30 illustrates a cross section view in partial cutaway of the modeof operation of the single operator exchange fluid jet thrombectomydevice 110 with particular attention to the distal end 120 of thecrossflow/flow director 116 a and the flexible tapered tip 117positioned in a blood vessel 156, artery or the like at the site of athrombotic deposit or lesion 158. High velocity jet flow 152 of saline(or other suitable fluid) is shown being emitted in a proximal directionfrom the jet emanator 52 to sealingly expand the exhaust tube 122 of thecrossflow/flow director 116 a and to impinge upon and carry awaythrombotic deposits or lesions 158. Other jet emanators can beincorporated at the distal end 50 of the second tube 42 as analternative to the jet emanator 52 illustrated in this figure to emanateor emit one or more high velocity jet flow(s) 152 distally along or nearthe longitudinal axis of the second tube 42 and the exhaust tube 122 toaccomplish the same purpose as that described for the jet emanator 52.The high velocity jet flow(s) 152 of saline pass outwardly through theoutflow orifice(s) 134 in a radial direction creating crossflow jet(s)160 (lower velocity jet(s)) directed outwardly toward the wall of theblood vessel 156 and are influenced by the low pressure at the infloworifice(s) 136 to cause the crossflow jet(s) 160 to flowcircumferentially and distally to impinge on, provide drag forces on,and break up thrombotic deposits or lesions 158 and to, by entrainment,urge and carry along the particles of thrombotic deposits or lesions 158through the inflow orifice(s) 136, a relatively low pressure region,into the high velocity jet flows 152 where the thrombus is furthermacerated into microscopic particles, and into the exhaust lumen 154(FIG. 24). The entrainment through the inflow orifice(s) 136 is based onentrainment by the high velocity jet flow(s) 152. The outflow is drivenby internal pressure which is created by the high velocity jet flow(s)152 and the fluid entrained through the inflow orifice(s) 136. Enhancedclot removal is attainable because of the recirculation patternestablished between inflow and outflow orifices 136 and 134, whichcreates a flow field that maximizes drag force on wall-adhered thrombus.Since the entrained thrombus is macerated into microscopic particles,those particles that exit the outflow orifices 134 are not of sufficientsize to significantly block the distal circulation, and will bere-entrained into the inflow orifices 136 at a high rate.

FIGS. 31 and 32, a ninth alternative embodiment, illustrate an explodedview and an assembled view of a jet emanator in the form of a jet cap220, which can be utilized in the inner catheter assembly 114 of thesingle operator fluid jet exchange thrombectomy device 110. The jet cap220 is substantially a combination of an emanator and an inner body andthe jet cap 220 can be utilized in lieu of the jet emanator 52, morespecifically designated as a toroidal loop 52 a, and the inner body 130.One portion of the jet cap 220 includes a main cylindrical-like body 222having opposing annular rings 224 and 226 extending from the endsthereof, a guidewire lumen 228 extending through the main body 222, anannular extension 230 extending outwardly from one end of the main body222 and having an annular surface 232 which lies in the same plane as anannular surface 234 of the annular ring 224, an annulus 236 between oneend of the main body 222, the annular ring 224 and the annular extension230, and an annular extension 238 extending outwardly from and beyondthe annular surface 232 of the annular extension 230. Another portion ofthe jet cap 220 includes a round plate 240 including a central hole 242,a receptor hole 224 for accommodation of a second tube 42, and aplurality of jet orifices 246 a-246 n aligned concentric to the centralhole 242.

FIG. 33 illustrates a cross section view of the jet cap 220 along line33—33 of FIG. 32, where all numerals correspond to those elementspreviously described. The central hole 242 of the round plate 240utilizes the annular extension 238 to align the round plate 240 to theannular surface 232 and the annular surface 234 of the annular ring 224and is suitably secured thereto. Such close alignment seals to theannulus 236 which forms a circular chamber for the distribution of highpressure saline through the sealed annulus 236. Annular rings 224 and226 can engage and are fixed in the interior annular surface 64 of anexhaust tube 122. High pressure saline is delivered to the second tube42, which suitably secures in the receptor hole 244 located on the roundplate 240 and as such is distributed through the sealed annulus 236 toemanate high pressure saline jet flow through the rearwardly directedjet orifices 246 a-246 n.

FIG. 34, a tenth alternative embodiment, illustrates an isometric jetemanator in the form of a jet cap 250 having formed passages containedtherein. The formed passage jet cap 250 has a one-piece body 252 whichincludes a rounded taper 254 tapering downwardly in the distaldirection. A guidewire lumen 256 extends longitudinally through the body252 extending between a proximal surface 258 and a distal surface 259. AU-shaped passageway 260, for the conveyance of high pressure saline, islocated interior to the body 252 and terminates at one end as a jetorifice 262 at the proximal surface 258 and at a receptor hole 264 forthe accommodation of a second tube 42 at the proximal surface 258. Inthe illustration, a second tube 42 is shown for delivery of highpressure saline to the passageway 260.

FIG. 35 illustrates a side view of the formed passage jet cap 250 in useas an emanator, such as in use with a flow director 48 a of a singleoperator fluid jet exchange thrombectomy device. The formed passage jetcap 250 can also be incorporated (not illustrated) with additionalproximally located structure having inflow and outflow orifices, such asinflow orifice(s) 136 and outflow orifice(s) 134 shown previously, tofunction with a crossflow/flow director for configuration and use as asingle operator jet exchange thrombectomy device having crossflowcapabilities.

FIG. 36 illustrates a proximal end view of the formed passage jet cap250.

FIG. 37, an eleventh alternative embodiment, illustrates a cross sectionview of an inner body 180 along line 37—37 of FIG. 38, and FIG. 38illustrates an end view of the inner body 180 along line 38—38 of FIG.37, which can be substituted at one end of the inner catheter assembly14. More specifically, the inner body 180 can be substituted for theflow director 48 a at the distal end 50 of the second tube 42. The innerbody 180, which is cylindrically shaped, can be of plastic or othersuitable material and includes a bore 181 for fixed accommodation of thesecond tube 42 extending longitudinally through the inner body 180 aswell as a guidewire passage 183 extending longitudinally through theinner body 180. The inner body 180 also includes a longitudinallyaligned exhaust lumen 182 extending through the inner body 180 tocommunicate with the lumen 100 of the first tube or guide catheter 32. Ajet emanator 184, which is curved, extends from the distal end 50 of thesecond tube 42 and is directed to align and to introduce a high pressuresaline jet 186 with the exhaust lumen 182. The high pressure saline jet186 transits a space 188 between the curved jet emanator 184 and thedistal end 190 of inner body 180 to contact and break away thromboticmaterial or lesions which are subsequently entrained therein to beevacuated via the exhaust lumen 182 and lumen 100 of the first tube orguide catheter 32 of the outer catheter assembly 12.

FIG. 39, a twelfth alternative embodiment, illustrates a cross sectionview of an inner body 200 along line 39—39 of FIG. 40, and FIG. 40illustrates an end view of the inner body 200 along line 40—40 of FIG.39, which can be substituted at one end of the inner catheter assembly14. More specifically, the inner body 200 can be substituted for theflow director 48 a at the distal end 50 of the second tube 42. The innerbody 200, which is cylindrically shaped, can be of plastic or othersuitable material and includes a bore 202 for fixed accommodation of thesecond tube 42 extending longitudinally through the inner body 200, aswell as a large multipurpose lumen 204 extending longitudinally throughthe inner body 200. The multipurpose lumen 204 serves as an exhaustlumen and as a passage for accommodation of a guidewire. Themultipurpose lumen 204 communicates with the lumen 100 of the first tubeor guide catheter 32. A jet emanator 206, which is curved, and which isoffset from the multipurpose lumen 204, extends from the distal end 50of the second tube 42 and is directed to align and to introduce a highpressure saline jet 208 with the multipurpose lumen 204. The highpressure saline jet 208 transits a space 210 between the curved jetemanator 206 and the distal end 212 of inner body 200 to contact andbreak away thrombotic material or lesions which are subsequentlyentrained therein to be evacuated via the multi-purpose lumen 204 andlumen 100 of the first tube or guide catheter 32 of the outer catheterassembly 12.

FIG. 41, a thirteenth alternative embodiment, illustrates a side view ofa manifold 285 and a view in partial cross section of a first tube orguide catheter 270 which can be incorporated substantially in lieu ofand resembling for the most a first tube or guide catheter 32,previously illustrated, including a distal end 272 which is tapered, apassage 273 for a guidewire, a proximal end 274, a Luer connection 276,manipulating tabs 278 and 280, a manifold branch 281 extending from thefirst tube or guide catheter 270 and a Luer connector 283 at the end ofthe manifold branch 281, and other members as now described. The firsttube or guide catheter 270 includes an inflatable balloon 282, shown inthe inflated mode, which is suitably secured to and which is locatedabout one end of and near the distal end 272 of the tubular structure. Alumen 284 for effluent evacuation extends along the interior of thefirst tube or guide catheter 270. An inflation lumen 286 partiallyutilizing the interior wall 288 extends partially along the length ofthe lumen 284 and connects with the manifold branch 281 and Luerconnector 283 to communicate with and for inflation of the balloon 282.Manifold 285, similar to manifold 20 of FIG. 2, is provided including ahemostasis nut/stop 287 secured in the proximal end 289 of the manifold285, a Luer connection 291 located at the proximal end 293 of an angledmanifold branch 295 extending from the manifold 285 and a Luer fitting297 at the distal end 299 of the manifold 285.

FIG. 42 illustrates the first tube or guide catheter 270 in use in ablood vessel 275. The inflatable balloon 282 which inflates to contactand seal against the blood vessel 275 provides for a region of proximalocclusion 292 with respect to the location of the inflated balloon 282,that region extending proximally from the inflated balloon 282 betweenthe first tube or guide catheter 270 and the blood vessel 275. Such aregion of proximal occlusion 292 prevents thrombotic deposits or lesionsfrom traveling proximally along and about the exterior of the first tubeor guide catheter 270 and the interior of the blood vessel 275 andensures removal of the thrombotic deposits or lesions along and throughthe lumen 284. Cessation of flow also minimizes the possibility ofdistal embolization of thrombotic debris. Inflation of the balloon 282provides for centering of the first tube or guide catheter 270 and asuitable jet emanator within the blood vessel 275 to provide forcentrally located and evenly applied saline emanation which can alsopreclude having the jetted saline emitted dangerously close to the wallof the blood vessel 275. Such centering allows for more powerful suctionwithout damage to the blood vessel wall.

FIG. 43, a fourteenth alternative embodiment, includes the componentsand members described in FIG. 41, including an additional inflatableballoon 294 located proximal to the inflatable balloon 282 to provide afirst tube or guide catheter 296 which can be incorporated substantiallyin lieu of and resembling for the most a first tube or guide catheter32, previously illustrated, including a distal end 272 which is tapered,a passage 273 for a guidewire, a proximal end 274, a Luer connection276, manipulating tabs 278 and 280, a manifold branch 281 extending fromthe first tube or guide catheter 270 and a Luer connector 283 at the endof the manifold branch 281, and other members as now described. Thefirst tube or guide catheter 296 includes inflatable balloons 282 and294 shown in the inflated mode, which are suitably secured to and one ofwhich, inflatable balloon 282, is located about one end of and near thedistal end 272 of the tubular structure and the other inflatable balloon294 is located proximally and opposingly with respect to the inflatableballoon 282 on the tubular structure. A lumen 284 for effluentevacuation extends along the interior of the first tube or guidecatheter 296. An inflation lumen 286 a partially utilizing the interiorwall 288 extends the length of the lumen 284 and connects with themanifold branch 281 and the Luer connector 283 to communicate with andfor inflation of the balloons 282 and 294. A plurality of infloworifices 298 a-298 n are included in the tubular structure to providefor suction of thrombus or other effluent through a flow director 300,shown representatively in dashed lines in FIG. 44.

FIG. 44 illustrates the first tube or guide catheter 296 in use in ablood vessel 275. The inflatable balloons 282 and 294 which are inflatedto contact and seal against the blood vessel 275 provide for a sealedregion 302 extending proximally from the inflated balloon 282 anddistally from the inflated balloon 294, between the first tube or guidecatheter 296 and the blood vessel 275. Such a sealed region 302 ofocclusion contains thrombotic deposits or lesions about the exterior ofthe first tube or guide catheter 296 and between the inflatable balloons282 and 294 and ensures removal of the thrombotic deposits or lesionsthrough the flow director 300, the position of which can be variedlongitudinally. Such an arrangement is also helpful in preventingproximal and distal embolizations. Inflation of the inflatable balloons282 and 294 provides for centering of the first tube or guide catheter296 within the blood vessel 275 to provide for centrally located andevenly applied saline emanation which can also preclude having thejetted saline emitted dangerously close to the wall of the blood vessel275. Such centering allows for more powerful suction without damage tothe wall of the blood vessel 275.

FIG. 45, a fifteenth alternative embodiment, illustrates a side view ofa single operator exchange fluid jet thrombectomy device 310 which canbe incorporated for the removal of thrombus, and FIG. 46 illustrates asemi-exploded side view of the single operator exchange fluid jetthrombectomy device 310. The single operator exchange fluid jetthrombectomy device 310 includes two major assemblies: namely, an outercatheter assembly 12, as previously described in detail and which is acore assembly, and an inner catheter assembly 314 configured to functionas a thrombectomy catheter, which has been substituted or exchanged forthe previously described inner catheter assembly 14 and which is shownas an example of inner catheter assemblies which can be exchanged withother styles or designs of inner catheter assemblies as desired to fitsubstantially within and to be incorporated with the outer catheterassembly 12. The inner catheter assembly 314, when in use, aligns mostlywithin the outer catheter assembly 12 and extends beyond both ends ofthe outer catheter assembly 12, although the amount extending beyondboth ends is not necessarily illustrated proportionally. Both the outercatheter assembly 12 and the inner catheter assembly 314 align over andabout the guidewire 16 which includes a flexible tip 18 at one end and aproximal end 17 opposing the flexible tip 18. Externally visiblecomponents, or portions of components, of the outer catheter assembly 12correspond to the previous descriptions. Much of the structure of thepreviously described inner catheter assembly 14 is incorporated andutilized in the inner catheter assembly 314. Externally visiblecomponents or portions of components of the inner catheter assembly 314of the single operator exchange fluid jet thrombectomy device 310include the high pressure second tube 42, the transitional filterhousing/high pressure connection/stop assembly 44 concentrically alignedto and secured over and about the proximal end 46 of the second tube 42,and a jet emanator 52 consisting of a toroidal loop 52 a having apassage 53 (FIG. 22) at the distal end 50 of the second tube 42.Optionally, a jet cap, such as jet cap 54 of FIG. 2, can be includedover and about the jet emanator 52 consisting of a toroidal loop 52 a.The inner catheter assembly 314 is deployed within the outer catheterassembly 12 and is positioned to place the jet emanator 52 distal to thedistal end 60 of the first tube or guide catheter 32 by a distance of0.005 inch to 0.500 inch depending on the type of anatomy and materialto be removed.

FIG. 47 illustrates a cross sectional view along line 47—47 of FIG. 45of the single operator exchange fluid jet thrombectomy device 310looking distally. The alignment of the jet emanator 52, in this case, atoroidal loop 52 a, is such that saline jet flow 96 emanating from atleast one of the jet orifices 90 a-90 n will impinge the lumen 100 ofthe first tube or guide catheter 32 to provide stagnation pressure foreffluent evacuation. Other streams of saline jet flow 96 emanating fromthe jet orifices 90 a-90 n may not impinge the lumen 100, as the devicecan be tailored and configured for particular anatomy and material to beremoved to prevent undesirable damage from these jets. The saline jetflow emanating from the jet orifices 90 a-90 n creates suction andmaceration forces at the distal end 60 of the first tube or guidecatheter 32 for removal of undesirable material.

FIG. 48 illustrates the elements of FIG. 45 where the length of thesecond tube 42 is of a predetermined length, whereby the transitionalfilter housing/high pressure connection/stop assembly 44 impinges thehemostasis nut/stop 22 to limit the distance the jet emanator 52, inthis case a toroidal loop 52 a, can extend distally beyond the distalend 60 of the first tube or guide catheter 32 to prevent emanation ofsaline jet flow from one or more of the jet orifices 90 a-90 n from notimpinging the lumen 100 of the first tube or guide catheter 32 in orderto provide a maximum safe gap 316, the distance between the jet emanator52 and distal end 60 of the first tube or guide catheter 32, in order toavoid undesirable damage to a vessel wall.

FIG. 49 illustrates a side view, and FIG. 50 illustrates a semi-explodedside view, of the elements and features of FIGS. 45, 46, 47 and 48additionally including a centering ring 318 secured to the second tube42 slightly proximal to the jet emanator 52. The centering ring 318 isplaced such that it remains housed within the first tube or guidecatheter 32 to ensure coaxial positioning of the centering ring 318within the first tube or guide catheter 32. Such coaxial positioningensures impingement of the saline jet flow emanating from the jetorifices 90 a-90 n with the lumen 100 of the first tube or guidecatheter 32 and as such avoids having saline jet flow which does notimpinge the lumen 100 of the first tube or guide catheter 32.

FIG. 51 illustrates a cross section view of the single operator exchangefluid jet thrombectomy device 310 along line 51—51 of FIG. 49, whereinthe centering ring 318 is utilized. The centering ring 318 is sized toallow longitudinal movement within and along the lumen 100 of the firsttube or guide catheter 32. A centering ring surround 320 extendsinwardly from the centering ring 318 to surround and firmly attach tothe second tube 42. Such firm attachment maintains the alignedrelationship of the jet emanator 52, in this case a toroidal loop 52 a,with the second tube 42. The aligned relationship, of course, ismaintained as the second tube 42 is advanced to position the jetemanator 52 the desired distance beyond the distal end 60 of the firsttube or guide catheter 32 to ensure alignment of all of the jet orifices90 a-90 n with the lumen 100 at the distal end 60.

Various modifications can be made to the present invention withoutdeparting from the apparent scope hereof.

SINGLE OPERATOR EXCHANGE FLUID JET THROMBECTOMY DEVICE

PARTS LIST 10 single operator exchange fluid jet thrombectomy device 12outer catheter assembly 14 inner catheter assembly 16 guidewire 17proximal end (of guidewire) 18 flexible tip 20 manifold 22 hemostasisnut/stop 24 proximal end (of manifold) 26 Luer connection 28 proximalend (of manifold branch) 30 manifold branch 32 first tube or guidecatheter 33 proximal end (of first tube or guide catheter) 34 distal end(of manifold) 35 Luer connection 36 Luer fitting 38 manipulating tab 40manipulating tab 42 second tube 44 transitional filter housing/highpressure connection/stop assembly 46 proximal end (of second tube) 48a-doptional flow directors 50 distal end (of second tube) 52 jet emanator52a loop coil 53 passage 54 jet cap 55 passage 56 radio-opaque marker(at distal end of first tube or guide catheter) 57 distal end (ofexpandable exhaust tube) 58 radio-opaque marker (at distal end ofexpandable exhaust tube) 59 radio-opaque marker (at proximal end ofexpandable exhaust tube) 60 distal end (of first tube or guide catheter)62 distal end (of inner catheter assembly) 63 proximal end (ofexpandable exhaust tube) 64 interior annular surface 66 inner body 68annulus 70a outer annular surface 70b outer surface 72 exhaust tube 72acompliant expandable exhaust tube 72b non-compliant expandable exhausttube 72c non-expandable, non-compliant close fit exhaust tube 72dcompliant/ non-compliant exhaust tube 74 reduced radius neck 76 annularbarb 78 interior annular surface 80 slotted cutout 81 weld 82 passage 83weld 84 ramped annular surface 86 variable displacement distance 88space 90a-n jet orifices 92 capturing cavity 93 high pressure lumen 94saline 96 saline jet flow 98 lumen (of expandable exhaust tube) 100lumen (of first tube or guide catheter) 102a-b segments 104 blood vessel106 thrombotic deposit or lesion 110 single operator exchange fluid jetthrombectomy device 114 inner catheter assembly 116a-d crossflow/flowdirectors 117 flexible tapered tip 118 radio-opaque marker (at distalend of crossflow/flow director) 119 passage 120 distal end (ofcrossflow/flow director) 122 exhaust tube 122a compliant expandableexhaust tube 122b non-compliant expandable exhaust tube 122cnon-expandable, non-compliant close fit exhaust tube 122d compliant/non-compliant exhaust tube 124 distal end (of inner catheter assembly) 126radio-opaque marker (at proximal end of crossflow/flow director) 127radio-opaque marker 128 proximal end (of crossflow/flow director) 130inner body 134 outflow orifice 136 inflow orifice 138 annulus 140 outerannular surface 142 reduced radius neck 144 shoulder 146 passage 148variable displacement distance 150 saline 152 saline jet flow 154 lumen(of crossflow/flow director) 156 blood vessel 158 thrombotic deposit orlesion 160 crossflow jet(s) 170 outflow orifice(s) 172 crossflow jet 180inner body 181 bore 182 exhaust lumen 183 guidewire passage 184 curvedjet emanator 186 saline jet 188 space 190 distal end (of inner body 180)200 inner body 202 bore 204 multi-purpose lumen 206 curved jet emanator208 saline jet 210 space 212 distal end (of inner body 200) 214a-bsegments 220 jet cap 222 main body 224 annular ring 226 annular ring 228guidewire lumen 230 annular extension 232 annular surface 234 annularsurface 236 annulus 238 annular extension 240 round plate 242 centralhole 244 receptor hole 246a-n jet orifices 250 formed passage jet cap252 body 254 rounded taper 256 guidewire lumen 258 proximal surface 259distal surface 260 passageway 262 jet orifice 264 receptor hole 270first tube or guide catheter 272 distal end 273 passage 274 proximal end275 blood vessel 276 Luer connection 278 manipulating tab 280manipulating tab 281 manifold branch 282 inflatable balloon 283 Luerconnector 284 lumen 285 manifold 286 inflation lumen 286a inflationlumen 287 hemostasis nut/stop 288 interior wall 289 proximal end 291Luer connection 292 region of proximal occlusion 293 proximal end 294inflatable balloon 295 manifold branch 296 first tube or guide catheter297 Luer fitting 298a-n inflow orifices 299 distal end 300 flow director302 sealed region 310 single operator fluid jet thrombectomy device 314inner catheter assembly 316 maximum safe gap 318 centering ring 320centering ring surround

What is claimed is:
 1. A single operator exchange fluid jet thrombectomydevice, suitable for insertion into a body vessel or other body cavityin order to remove undesirable matter therefrom, the device comprising:a. an outer assembly including: (1) a manifold including a proximal endand a distal end; and, (2) a first tube extending from the distal end ofthe manifold, the first tube having a proximal end and an open distalend; b. at least one inner assembly, each inner assembly characterizedby an ability to separate from the outer assembly and be exchanged for adifferent inner assembly and to pass through the first tube of the outerassembly, and wherein at least one inner assembly includes: (1) a highpressure second tube having a proximal end, a distal end, a highpressure lumen, and a geometrically configured distally located jetemanator; and, (2) a flow director means attached to the high pressuresecond tube adjacent to, spaced apart from, and proximal to the jetemanator, the flow director means having a lumen; and, c. said flowdirector means and said first tube of said outer assembly defining anannulus and said flow director means positionable to at least partiallyrestrict the annulus thereby providing a substantial fluid seal meansbetween said flow director means and said first tube of said outerassembly.
 2. The single operator exchange fluid jet thrombectomy deviceof claim 1, wherein the flow director means of the at least one innerassembly includes: a. an inner body; and, b. an expandable exhaust tubehaving a pressure operated closeable or sealable outwardly directedannular surface for engaging an inwardly directed annular surface of theouter assembly.
 3. The single operator exchange fluid jet thrombectomydevice of claim 2, wherein the combination of the jet emanator and theinner body and the expandable exhaust tube, together, are characterizedby an ability to provide a localized region of low pressure associatedwith a fluid flow directed generally proximally and into the inner body,into the expandable exhaust tube, and through the first tube of theouter assembly.
 4. The single operator exchange fluid jet thrombectomydevice of claim 2, wherein lateral positioning of the high pressuresecond tube of the at least one inner assembly within the first tube ofthe outer assembly is enabled in a first unpressurized operational modewhere the closeable annular surface is not expanded and is prevented ina second pressurized operational mode where the closeable annularsurface is expanded to engage the at least one inner assembly to theouter assembly.
 5. The single operator exchange fluid jet thrombectomydevice of claim 4, wherein during the second pressurized operationalmode, jetted saline causes the expandable exhaust tube to expand, thuspartially or fully closing, restricting, modifying or eliminating theopen annulus to temporarily pressure seal the first tube to the highpressure second tube.
 6. The single operator exchange fluid jetthrombectomy device of claim 2, wherein lateral positioning of the highpressure second tube of the at least one inner assembly within the firsttube of the outer assembly is enabled in a first unpressurizedoperational mode where the closeable annular surface is not expanded andremains enabled in a second pressurized operational mode where thecloseable annular surface is expanded to slidingly seal and engage theat least one inner assembly to the outer assembly.
 7. The singleoperator exchange fluid jet thrombectomy device of claim 1, wherein thejet emanator at the distal end of the high pressure second tube has aproximal side and at least one jet orifice, wherein the at least one jetorifice has been formed by machining upon the proximal side of the jetemanator, so as to direct fluid from the jet emanator proximally forthrombus ablation and then subsequently through the lumen in the flowdirector means and through the first tube of the outer assembly.
 8. Thesingle operator exchange fluid jet thrombectomy device of claim 1,wherein the at least one inner assembly is capable of passage over aguidewire.
 9. The single operator exchange fluid jet thrombectomy deviceof claim 1, further comprising a variable displacement distance indexingmeans for enabling a selected positional relationship of the jetemanator to the open distal end of the first tube of the outer assembly.10. The single operator exchange fluid jet thrombectomy device of claim9, wherein said indexing means includes: a. a stop means provided forlimiting movement of the high pressure second tube including ahemostasis nut/stop at the proximal end of the manifold of the outerassembly; and, b. a high pressure connection/stop assembly projectingoutwardly from the proximal end of the high pressure second tube. 11.The single operator exchange fluid jet thrombectomy device of claim 1,further comprising: a. means for observing the relational spacingbetween the jet emanator and the open distal end of the first tube ofthe outer assembly comprising at least one observable component selectedfrom the list consisting of: radio-opaque marker, inner body, jet cap,flexible tapered tip.
 12. The single operator exchange fluid jetthrombectomy device of claim 1, wherein the manifold of the outerassembly includes a “Y” adapter, and the first tube of the outerassembly is a standard guide catheter.
 13. The single operator exchangefluid jet thrombectomy device of claim 1, wherein the jet emanatordistally located on the high pressure second tube includes a loop. 14.The single operator exchange fluid jet thrombectomy device of claim 1,wherein the jet emanator distally located on the high pressure secondtube includes a generally toroidal configuration.
 15. The singleoperator exchange fluid jet thrombectomy device of claim 1, wherein thehigh pressure second tube is a metallic tube.
 16. The single operatorexchange fluid jet thrombectomy device of claim 1, wherein the highpressure second tube is a plastic tube.
 17. The single operator exchangefluid jet thrombectomy device of claim 1, wherein a jet cap is mountedon the jet emanator.
 18. The single operator exchange fluid jetthrombectomy device of claim 17, wherein the jet cap functions to shielddesirable tissue from trauma during insertion of the at least one innerassembly.
 19. The single operator exchange fluid jet thrombectomy deviceof claim 17, wherein the jet cap functions to shield desirable tissuefrom trauma from jets of saline during thrombectomy.
 20. The singleoperator exchange fluid jet thrombectomy device of claim 1, wherein: a.the manifold of the outer assembly further includes a proximally locatedstationary stop; b. the high pressure second tube of the at least oneinner assembly of the array of inner assemblies further includes aproximally located transitional stop affixed to the high pressure secondtube adjacent to the proximal end of the high pressure second tube; and,c. said at least one inner assembly is movable axially within the outerassembly such that the proximally located transitional stop engages theproximally located stationary stop to hold the jet emanator in aselected relationship with respect to the open distal end of the firsttube of the outer assembly.
 21. The single operator exchange fluid jetthrombectomy device of claim 1, wherein the high pressure second tube ofthe at least one inner assembly of the array of inner assemblies has alength between the proximal and distal ends of the high pressure secondtube sufficient to allow the distal end of the high pressure second tubeto extend from the open distal end of the first tube of the outerassembly while the proximal end of the high pressure second tube extendsfrom the proximal end of the outer assembly so as to allow connection ofthe high pressure second tube to a high pressure fluid source.
 22. Thesingle operator exchange fluid jet thrombectomy device of claim 1,wherein the high pressure second tube includes a passage allowing the atleast one inner assembly to be passed over a standard guidewire.
 23. Thesingle operator exchange fluid jet thrombectomy device of claim 1,wherein the first tube of the outer assembly is characterized by anability to serve as a guide catheter.
 24. The single operator exchangewaterjet thrombectomy device of claim 1, wherein the jet emanator is acurved jet emanator.
 25. The single operator exchange waterjetthrombectomy device of claim 1, wherein the jet emanator includes a jetcap having passages therein.
 26. The single operator exchange fluid jetthrombectomy device of claim 1, wherein said annulus is restricted bysaid flow director means being in close proximity to said first tube ofsaid outer assembly so as to provide a substantial fluid seal betweensaid flow director means and said first tube of said outer assembly. 27.A single operator exchange fluid jet thrombectomy device for removal ofdeformable undesired matter from a body cavity or vessel, comprising: a.an outer assembly including: (1) a manifold including a proximallylocated stationary stop; and, (2) a first tube extending distally fromthe manifold, the first tube having a lumen with an open distal end; b.at least one inner assembly, each inner assembly characterized by anability to separate from the outer assembly and be exchanged for adifferent inner assembly and to pass through the lumen of the first tubeof the outer assembly, and wherein at least one inner assembly includes:(1) a high pressure second tube and having a proximal end, a distal end,a high pressure lumen, and a geometrically configured distally locatedjet emanator having one or more proximally directed orifices; and, (2) acrossflow director means, attached to the high pressure second tubeadjacent to, spaced apart from, and proximal to the jet emanator, thecrossflow director means having an outflow orifice and an infloworifice, the crossflow director means designed for redirecting jet flowemanating from the jet emanator and fluid entrained through the infloworifice out of the outflow orifice; and, c. said crossflow directormeans and said first tube of said outer assembly defining an annulus andsaid crossflow director means positionable to at least partiallyrestrict the annulus thereby providing a substantial fluid seal betweensaid crossflow director means and said first tube of said outerassembly.
 28. The single operator exchange fluid jet thrombectomy deviceof claim 27, wherein the at least one inner assembly of the arrayfurther includes a proximally located transitional stop fixed to thehigh pressure second tube adjacent to the high pressure second tubeproximal end, and wherein said at least one inner assembly is movableaxially within the outer assembly such that the proximally locatedtransitional stop engages the proximally located stationary stop to holdthe jet emanator and crossflow director means in a selected spaced apartrelationship with respect to the open distal end of the lumen of thefirst tube of the outer assembly.
 29. The single operator exchange fluidjet thrombectomy device of claim 28, wherein the high pressure secondtube of the at least one inner assembly of the array of inner assemblieshas a length between the proximal and distal ends of the high pressuresecond tube sufficient to allow the distal end of the high pressuresecond tube to extend from the open distal end of the lumen of the firsttube of the outer assembly while the proximal end of the high pressuresecond tube extends from the proximal end of the outer assembly so as toallow connection of the high pressure second tube to a high pressurefluid source.
 30. The single operator exchange fluid jet thrombectomydevice of claim 29, wherein the high pressure second tube includes apassage allowing the at least one inner assembly to be passed over astandard guidewire.
 31. The single operator exchange fluid jetthrombectomy device of claim 28, wherein the jet emanator includes atoroidal loop.
 32. The single operator exchange fluid jet thrombectomydevice of claim 28, wherein the jet emanator is a curved jet emanator.33. The single operator exchange fluid jet thrombectomy device of claim28, wherein the jet emanator includes a jet cap having passages therein.34. A small profile, rapid exchange device system suitable for insertioninto a synthetic or biologic body vessel, cavity or organ in order totreat or diagnose an undesirable condition therein, the devicecomprising: a. an outer assembly including: (1) a manifold; and, (2) afirst tube extending distally from the manifold and having a lumen withan open distal end; b. at least one inner assembly, each inner assemblycharacterized by an ability to separate from the outer assembly and topass through the manifold and lumen of the first tube of the outerassembly, and wherein at least one inner assembly includes: (1) a distalemanator for directing energy in close approximation to the undesirablecondition in order to treat or diagnose the undesirable condition; (2) aflow director means; and, (3) a means for determining the relationshipof the distal emanator of the at least one inner assembly with respectto the open distal end of the lumen of the first tube of the outerassembly such that alternatively: (a) the lumen of the first tube of theouter assembly functions as a supply lumen for a material to be infusedin close approximation to the undesirable condition to act together withthe distal emanator to aid in treating or diagnosing the undesirablecondition; and, (b) the lumen of the first tube of the outer assemblyfunctions as an exhaust lumen for infused materials, lysed tissue orother undesirable materials associated with treating the undesirablecondition; and, c. said flow director means and said first tube of saidouter assembly defining an annulus and said flow director meanspositionable to at least partially restrict the annulus therebyproviding a substantial fluid seal between said flow director means andsaid first tube of said outer assembly.
 35. A small profile, rapidexchange device system suitable for insertion into a synthetic orbiologic body vessel, cavity or organ in order to lyse thrombus, tissueor other undesirable matter therein, the device comprising: a. an outerassembly including: (1) a manifold; and, (2) a first tube extendingdistally from the manifold and having a lumen with an open distal end;b. at least one inner assembly, each inner assembly characterized by anability to separate from the outer assembly and to pass through themanifold and lumen of the first tube of the outer assembly, and whereinat least one inner assembly includes: (1) a distal emanator fordirecting energy in close approximation to the undesirable matter inorder to aid in disrupting or lysing the undesirable matter; (2) a flowdirector means; and, (3) a means for determining the relationship of thedistal emanator of the at least one inner assembly with respect to theopen distal end of the lumen of the first tube of the outer assemblysuch that a material supplied through the lumen of the first tube of theouter assembly may be infused in close approximation to the undesirablematter in order to act together with the distal emanator to aid indisrupting or lysing the undesirable matter; and, c. said flow directormeans and said first tube of said outer assembly defining an annulus andsaid flow director means positionable to at least partially restrict theannulus thereby providing a substantial fluid seal between said flowdirector means and said first tube of said outer assembly.
 36. A smallprofile, rapid exchange device system suitable for insertion into asynthetic or biologic body vessel, cavity or organ in order to lysethrombus, tissue or other undesirable matter therein, the devicecomprising: a. an outer assembly including: (1) a manifold; and, (2) afirst tube extending distally from the manifold and having a lumen withan open distal end; and, b. at least one inner assembly, each innerassembly characterized by an ability to separate from the outer assemblyand be exchanged for a different inner assembly and to pass through themanifold and lumen of the first tube of the outer assembly, and whereinat least one inner assembly includes: (1) a distal emanator fordirecting energy in close approximation to the undesirable matter inorder to aid in disrupting or lysing the undesirable matter; (2) a flowdirector means; and, (3) a means for determining the relationship of thedistal emanator of the at least one inner assembly with respect to theopen distal end of the lumen of the first tube of the outer assemblysuch that the undesirable matter may be exhausted through the lumen ofthe first tube of the outer assembly; and, c. said flow director meansprovides a substantial fluid seal between said flow director means andsaid first tube of said outer assembly.
 37. A small profile, rapidexchange device system suitable for insertion into a synthetic orbiologic body vessel, cavity or organ in order to lyse thrombus, tissueor other undesirable matter therein, the device comprising: a. an outerassembly including: (1) a manifold; and, (2) a first tube extendingdistally from the manifold and having a lumen with an open distal end;and, b. at least one inner assembly, each inner assembly characterizedby an ability to separate from the outer assembly and be exchanged for adifferent inner assembly passed within the and lumen of the first tubeof the outer assembly, and wherein at least one inner assembly includes:(1) a distal emanator for directing energy in close approximation to theundesirable matter in order to aid in disrupting or lysing theundesirable matter; (2) a flow director means; and, (3) a means fordetermining the relationship of the distal emanator of the at least oneinner assembly with respect to the open distal end of the lumen of thefirst tube of the outer assembly such that alternatively: (a) a materialsupplied through the lumen of the first tube of the outer assembly maybe infused in close approximation to the undesirable matter in order toact together with the distal emanator to aid in disrupting or lysing theundesirable matter; and, (b) the undesirable matter together with anyinfused material may be exhausted through the lumen of the first tube ofthe outer assembly; and, c. said flow director means provides asubstantial fluid seal between said flow director means and said firsttube of said outer assembly.
 38. A small profile, rapid exchange fluidjet thrombectomy device, suitable for insertion into a body vessel orother body cavity in order to remove undesirable matter therefrom, thedevice comprising: a. an outer assembly including: (1) a manifoldincluding a proximally located stationary stop; and, (2) a first tubeextending distally from the manifold, the first tube having a lumen withan open distal end, the lumen of the first tube having at least a firstdiameter; and, b. at least one inner assembly, each inner assemblycharacterized by an ability to separate from the outer assembly and topass through the first diameter of the lumen of the first tube of theouter assembly, and wherein at least one inner assembly includes: (1) ahigh pressure second tube having a high pressure lumen and ageometrically configured distally located jet emanator having one ormore rearwardly directed jet orifices; and, (2) a flow director meansattached to the high pressure second tube adjacent to, spaced apartfrom, and proximal to the jet emanator; and, c. a substantial fluid sealbetween said flow director means and said first tube of said outerassembly.
 39. A catheter device for use with an outer assembly havingfirst tubular means for passage of fluid or other material with aproximal end and a distal end and with at least one passage along thelength thereof, said catheter device comprising: a. second tubular meansfor passage of fluid along the length thereof, with a proximal end and adistal end; b. jet emanator means for directing at least one fluid jetin the vicinity of said distal end of said second tubular means, saidjet emanator means having at least one jet orifice positioned to directat least one fluid jet in a generally proximal direction, said jetemanator means being in fluid communication with said second tubularmeans; c. connection means in fluid connection with said second tubularmeans located in the vicinity of said proximal end of said secondtubular means, said connection means providing for supply of fluid tosaid second tubular means, and thereby providing for supply of fluid tosaid jet emanator means so that fluid emanates from said at least onejet orifice to form at least one fluid jet and entrains fluid or othermaterial from the vicinity of said at least one fluid jet; d. flowdirector means located in the vicinity of said at least one jet orifice,said flow director means configured to direct flow from at least one ofsaid at least one fluid jet(s) into said distal end of said at least onepassage of said outer assembly; e. said jet emanator means and said flowdirector means being adapted to entrain material from the vicinity ofsaid at least one fluid jet and drive fluid and entrained materialtoward said proximal end of said outer assembly; f. said catheter devicebeing removably insertable into said at least one passage of said outerassembly; and, g. said flow director means providing a substantial fluidseal between said flow director means and the first tubular means ofouter assembly.
 40. The catheter device of claim 39, further comprising:a. inflow means and outflow means in said flow director means; b. saidinflow means providing passage for fluid and entrained material to bedrawn into said flow director means; and, c. said outflow meansproviding passage for at least some of said fluid and entrained materialin said flow director means to flow through said outflow means and awayfrom said flow director means.
 41. A catheter system for use in a bodyvessel or cavity for diagnosing or treating a condition comprising: a.an outer catheter with a proximal end and a distal end and at least afirst passage along the length thereof; b. an inner assembly with aproximal end and a distal end and at least one tube with at least asecond passage along the length thereof, and a jet emanator near thedistal end thereof, said second passage being connectable to a source offluid so that when so connected, fluid emanates from said jet emanatorto form at least one fluid jet; c. a flow director means in the vicinityof said jet emanator, said flow director means being attached to saidinner assembly, said flow director means having an extent that issubstantially shorter than said outer catheter; d. said inner assemblybeing insertable into and removable from said outer catheter; e. saidflow director means providing a substantial fluid seal between said flowdirector means and said first passage; and, f. said inner assembly beingpositionable in said outer catheter to a position in which said flowdirector means causes at least some flow to pass along said firstpassage.
 42. The catheter system of claim 41, further comprising atleast one alternate inner assembly insertable into said outer catheter,said at least one alternate inner assembly being useable to aid indiagnosing or treating a condition in a body vessel or cavity.
 43. Thecatheter system of claim 41, further comprising an alternate innerassembly having a dilation balloon, said alternate inner assembly beinginsertable into said outer catheter.
 44. The catheter system of claim41, further comprising means for indexing an appropriate positional andvariable relationship of said flow director means with respect to saiddistal end of said outer catheter.
 45. A multi-part catheter devicecomprising: a. an outer catheter with a proximal end and a distal endand at least a first passage extending between said proximal end andsaid distal end; b. an inner assembly with a proximal end and a distalend; c. said inner assembly being longer than said outer catheter, andbeing removably insertable into said outer catheter so that said distalend of said inner assembly can extend past said distal end of said outercatheter while said proximal end of said inner assembly extends pastsaid proximal end of said outer catheter; d. a flow director means witha proximal end and a distal end and at least one passage extendingbetween said proximal end and said distal end, said flow director meansbeing attached to said inner assembly and being located near said distalend of said inner assembly and being substantially shorter than saidinner assembly; e. said inner assembly being positionable in said outercatheter so that said flow director means extends at least in part pastsaid distal end of said outer catheter; f. said flow director meansbeing in close proximity to said outer catheter so as to provide asubstantial fluid seal between said flow director means and said outercatheter; and, g. said proximal end of said flow director means beingconfigured to communicate with said first passage of said outer catheterto allow fluid or other matter to pass between said flow director meansand said outer catheter.
 46. A fluid jet thrombectomy device, suitablefor insertion into a body vessel or other body cavity in order to removeundesirable matter therefrom, the device comprising: a. an outerassembly including: (1) a manifold including a proximally locatedstationary stop; and, (2) a first tube extending distally from themanifold, the first tube having a lumen with an open distal end, thelumen of the first tube having at least a first diameter; and, b. atleast one inner assembly, each inner assembly characterized by anability to separate from the outer assembly and to pass through thefirst diameter of the lumen of the first tube of the outer assembly, andwherein at least one inner assembly includes: (1) a high pressure secondtube having a high pressure lumen and a distally located jet emanator;(2) a proximally located transitional stop; and, (3) a flow directormeans attached to the high pressure second tube; and, c. said flowdirector means being in close proximity to said first tube of said outerassembly so as to provide a substantial fluid seal between said flowdirector means and said first tube of said outer assembly.
 47. The fluidjet thrombectomy device of claim 46, wherein said flow director meanscomprises a crossflow director means.
 48. A single operator exchangefluid jet thrombectomy device, suitable for insertion into a body vesselor other body cavity in order to remove undesirable matter therefrom,the device comprising: a. an outer assembly including: (1) a manifoldincluding a proximal end and a distal end; and, (2) a first tubeextending from the distal end of the manifold, the first tube having aproximal end and an open distal end; b. at least one inner assembly,each inner assembly characterized by an ability to separate from theouter assembly and be exchanged for a different inner assembly and topass through the first tube of the outer assembly, and wherein at leastone inner assembly includes: (1) a high pressure second tube having aproximal end, a distal end, a high pressure lumen, and a geometricallyconfigured distally located jet emanator, said jet emanator comprising ajet cap having passages therein; and, (2) a flow director means attachedto the high pressure second tube adjacent to, spaced apart from, andproximal to the jet emanator, the flow director means having a lumen.49. A fluid jet thrombectomy device, suitable for insertion into a bodyvessel or other body cavity in order to remove undesirable mattertherefrom, the device comprising: a. an outer assembly including: (1) amanifold including a proximally located stationary stop; and, (2) afirst tube extending distally from the manifold, the first tube having alumen with an open distal end, the lumen of the first tube having atleast a first diameter; and, b. at least one inner assembly, each innerassembly characterized by an ability to separate from the outer assemblyand to pass through the first diameter of the lumen of the first tube ofthe outer assembly, and wherein at least one inner assembly includes:(1) a high pressure second tube having a high pressure lumen and adistally located jet emanator, said jet emanator comprising a jet caphaving passages therein; (2) a proximally located transitional stop;and, (3) a flow director means attached to the high pressure secondtube.